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dennis100
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« on: December 17, 2018, 03:11:25 AM »

Model Number MODEL 250
Event Date 05/30/2012
Event Type  Malfunction   
Event Description
It was initially reported that the company representative was having problems with her handheld. For the handheld to charge, the serial cable has to be manipulated a certain way. A replacement serial cable was sent to the company representative, but it did not fix the issue. The handheld and both serial cables were returned to the manufacturer for evaluation. Product analysis is planned, but has not been completed.

Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received that the product analysis was completed on the handheld and flashcard. No anomalies associated with the serial cables were identified during the analysis. An analysis was performed on the returned handheld and the reported allegation was verified. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2624247
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dennis100
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« Reply #1 on: December 17, 2018, 03:12:05 AM »

Model Number 250
Event Date 11/01/2010
Event Type  Malfunction   
Event Description
It was initially reported by the company rep that the pt's new generator could not be interrogated in the operating room during initial implant surgery. It was observed in the operating room that the handheld had a bad connection and was causing the failure to program event. New programming system was shipped to the company rep and her old system was returned for analysis. Analysis was completed on the handheld and the reported allegation was verified. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. The cause for the damage to the connector could not be determined based on the returned handheld. However, based on the damaged connector, it is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a serious injury or death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1940651
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dennis100
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« Reply #2 on: December 17, 2018, 03:13:23 AM »

Model Number 250
Event Date 05/09/2013
Event Type  Malfunction   
Manufacturer Narrative
The initial report inadvertently listed the incorrect device name. The initial report inadvertently listed the incorrect date. Review of the handheld computer device history records confirmed all quality tests were passed prior to distribution.

Manufacturer Narrative

Event Description
A vns consultant reported that her handheld computer was not turning on. She stated that it has been charging since yesterday, and she tried charging it on different outlets. She also noted that the light was on when it was plugged in. It was confirmed that the lock button was not engaged. A hard reset was performed which still did not resolve the issue. The handheld was returned for analysis and is pending completion.

Event Description
Analysis was performed on the returned handheld, and the reported allegation was verified. During the analysis, it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. During the analysis of the returned software/flashcard, it was identified that the flashcard contained two different sets of patient databases. The likely cause for the multiple databases is associated with the flashcard being inserted into multiple devices. No other anomalies were identified. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3144570
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dennis100
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« Reply #3 on: December 17, 2018, 03:14:07 AM »

Model Number MODEL 250
Event Date 09/19/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the handheld has been giving continuous problems, including frozen screen issues, not being fully rechargeable event while continuously being on the charger, and going into sleep mode. A hard reset was performed, but it was not successful. The screen was cleaned and the battery removed, but the issue was not resolved. The device was returned for product analysis. Analysis was performed on the returned handheld and the reported allegation was not verified. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that some of the sync cable connector leads were damaged and that some of the solder connections between the sync cable connector leads and the pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. An analysis was performed on the returned flashcard and the reported allegation was not verified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3413564
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dennis100
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« Reply #4 on: December 17, 2018, 03:15:17 AM »

Model Number MODEL 250
Event Date 02/27/2013
Event Type  Malfunction   
Event Description
Product analysis was completed on (b)(6) 2013. Analysis was performed on the returned handheld. The handheld was received without an ac adapter. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the handheld circuit board and attached cable receptacle. Additionally, it was identified that the handheld would not power on. The cause for the anomaly is associated with a swollen main battery that prevented main battery cover from seating properly and registering a false open battery latch condition. Although the main battery was swollen, it was able to hold a charge and power the handheld for over an hour. No other anomalies were identified. An analysis was performed on the returned flashcard, and no anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

Manufacturer Narrative

Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.

Event Description
On (b)(4) 2013, it was reported that a handheld device had a connection problem, and the battery did not charge. The handheld device and software flashcard were received on (b)(4) 2013 and are currently undergoing product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3020015
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dennis100
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« Reply #5 on: December 17, 2018, 03:16:06 AM »

Model Number MODEL 250
Event Date 09/01/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis was performed on the returned handheld and no communication anomalies were identified. An analysis of the handheld identified that some of the solder connections between the sync cable connector leads and the handheld printed circuit board (pcb) were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. Additionally, it was also identified that the serial cable had an open electrical connection in the power cable. As a result of the open wire connection, the handheld would receive power from the ac adapter intermittently. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
It was reported that the nurse¿s handheld device was having intermittent communication issues. The handheld was used with a known functional wand but the issues were not resolved. The handheld device has been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3753821
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dennis100
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« Reply #6 on: December 17, 2018, 03:17:21 AM »

Model Number MODEL 250
Event Date 01/15/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received that the handheld and flashcard were returned to the manufacturer for evaluation. The handheld was received without an ac adapter. During the analysis it was identified that the main battery was inserted backwards. As a result, the handheld was unable to be powered using the retuned battery. Additionally, it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the handheld pcb and attached cable receptacle. No other anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

Manufacturer Narrative

Event Description
It was initially reported that the physician's handheld would only work when the ac cord was held a certain way. The handheld would only charge or connect if held in place. Good faith attempts for product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2957746
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dennis100
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« Reply #7 on: December 17, 2018, 03:18:31 AM »

Model Number MODEL 250
Event Date 05/20/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that there was a problem with the programming system. It was stated that the problem was narrowed down to the connector between the wand and the handheld. It was reported that the handheld and serial cable would be returned to the manufacturer for product analysis.

Manufacturer Narrative
The sync cable connector on the bottom of the handheld was damaged.

Manufacturer Narrative

Event Description
On (b)(4) 2013 the handheld and flashcard were returned for product analysis. Product analysis was completed on the handheld and flashcard on (b)(4) 2013. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. No anomalies associated with the serial cable were identified during the analysis. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167089
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dennis100
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« Reply #8 on: December 17, 2018, 03:19:44 AM »

Model Number MODEL 250
Event Date 10/22/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the handheld would freeze during interrogation and a soft reset would temporarily fix the problem, but it would eventually occur again. Troubleshooting was performed by the manufacturer's representative, but the issue could not be duplicated. The physician stated the problem is intermittent and does not occur everytime.

Manufacturer Narrative

Event Description
No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. During the analysis of the handheld it was identified that some of the sync cable connector leads were damaged and that some of the solder connections between the sync cable connector leads and the pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Attempts for additional information have been unsuccessful. No other information has been provided. Review of the handheld device history records confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3474734
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dennis100
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« Reply #9 on: December 17, 2018, 03:21:04 AM »

Model Number 250
Event Date 06/10/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Product analysis for the returned handheld programmer was completed and confirmed the battery cover was missing. Also, during analysis, it was identified the handheld would not power on using the ac adapter. The cause for the anomaly was associated with damaged leads associated with the handheld sync connector. Due to the damage, the handheld was unable to received power from the ac adapter. The cause for the damage to the connector leads and the solder connections is most likely associated with mishandling of the device as it appeared the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Product analysis for the returned software associated with the handheld programming system was completed. Analysis on the flashcard found no anomalies associated with the flashcard software or databases. The flashcard and software performed according to functional specifications.

Event Description
It was reported that the physician's handheld programmer was found in the corner of the clinic by a company representative. The handheld programmer was found uncharged and without a back, making it inoperable. No patients were impacted and it was unknown by the clinic when the back of the handheld programmer was lost and what may have happened to the back. The handheld programmer is expected to be returned for analysis, but has not been received to date.

Event Description
The handheld programming computer and associated hardware were received by the manufacturer for analysis. Analysis is expected, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5769609
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dennis100
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« Reply #10 on: December 17, 2018, 03:21:58 AM »

Model Number MODEL 250
Event Date 04/02/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
A company representative indicated that the handheld was not holding a charge. It was reported that the handheld was left plugged into the outlet all night and when unplugged the handheld immediately lost the charge. The handheld was plugged into another outlet which did not resolve the issue. A new handheld was provided to the company representative and the handheld and flashcard that would not charge were returned to manufacturer for analysis. Analysis of the handheld was completed on (b)(4) 2014. During the analysis, it was identified that some of the sync cable connector leads were damaged and that some of the solder connections between the sync cable connector leads and the handheld pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was received on (b)(4) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3782117
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dennis100
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« Reply #11 on: December 17, 2018, 03:24:06 AM »

Model Number MODEL 250
Event Date 03/21/2012
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #1 inadvertently did not report that the serial cable was also received by the manufacturer.

Event Description
The dell x50 computer and software was received by the manufacturer on (b)(6) 2012, and product analysis was completed. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Analysis of the returned computer was performed, and the reported allegation was not verified. No anomalies associated with the main battery were identified during the analysis. During the analysis, it was identified that the sync cable connector on the bottom of the handheld was damaged. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that a physician's dell x50 handheld device was not holding a charge, and therefore he wanted it replaced. The handheld read that the main battery was critical low, and he was unable to use the device. The device was typically stored in a cabinet, and no user mishandling was reported that may have contributed to the event. The physician was sent a new handheld device. Return of the suspect dell x50 handheld device is expected, but it has not been received to date.
 
Event Description
The physician's serial cable were also received by the manufacturer on (b)(6) 2012, with the handheld computer and flashcard, and the product analysis was completed with the suspect serial cable.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2535383
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dennis100
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« Reply #12 on: December 17, 2018, 03:25:03 AM »

Model Number MODEL 250
Event Date 08/31/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012, it was reported that a physician's handheld device would not turn on. A hard reset was performed; however, this did not resolve the issue. It was noted that when the hhd was plugged in, the orange indicator light on the handheld device would not come on; however, the charger was determined to be functional as it worked for another handheld device. It was later reported that the device was stored safely, and there was no mishandling. The handheld device and software flashcard were received on (b)(4) 2012. Product analysis was approved on (b)(4) 2012. An analysis was performed on the returned flashcard, and no anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified.

Manufacturer Narrative
Device failure occurred but did not cause or contribute to serious injury or death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2756961
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dennis100
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« Reply #13 on: December 17, 2018, 03:26:20 AM »

Model Number 250
Event Date 07/28/2012
Event Type  Malfunction   
Event Description
A site reported that their handheld computer may have a short in the cord. They reported that it seems to go off and on when sitting on the table plugged into the outlet. They reported that there is a short or it is not making the connection at the connector between the handheld and the cord. No visual issue was seen and the event was reported to be happening for about a month. The handheld has been returned for analysis and completion is pending.

Event Description
Analysis was performed on the returned handheld and the reported allegation was verified. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Non-responsiveness from the handheld is due to a damaged connector receptacle where the serial data cable normally attaches; receptacle became partially separated from the main pcb with some broken connector pins; most likely associated with wear or excessive cable manipulation an analysis was performed on the returned flashcard and the reported allegation was verified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

Manufacturer Narrative

Manufacturer Narrative
Device malfunction occurred but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2756491
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dennis100
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« Reply #14 on: December 17, 2018, 03:27:40 AM »

Model Number MODEL 250
Event Date 07/23/2012
Event Type  Malfunction   
Event Description
The handled computer and related software were received for product analysis on (b)(6) 2012. An analysis was performed on the returned handheld, and no anomalies associated with the main battery were noted during testing. However, it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

Manufacturer Narrative

Manufacturer Narrative
Describe event or problem - corrected data: it was reported that the charger would not charge multiple handhelds, however this was incorrect as the charge was used successfully to charge a different device.

Event Description
It was reported by a manufacturer's representative that her handheld would not hold a charge. The cables were checked and they appeared to be ok. At that time, the handheld was plugged back in and the bar showed that it was charging the battery or at least receiving power from the power cord. It appeared at that time that the issue had resolved. However it was then reported on (b)(6) 2012, that it was continuing to have problems as the handheld would again not turn on. On (b)(6) 2012, it was indicated that when the handheld was plugged into the charger, the power light would blink red, but will not turn on. Additionally the representative reported that her charger would not work to charge another handheld device. The handheld has yet to be returned to the manufacturer for analysis.
 
Event Description
The lot number and version number of the software was determined. Additionally it was inadvertently reported that the "charger would not work to charge another handheld device", however the charger was successfully used to charge a different handheld device without issue. The handheld has not been returned to the manufacturer to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2736514
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« Reply #15 on: December 17, 2018, 03:28:55 AM »

Model Number MODEL 250
Event Date 10/03/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012 it was reported that the handheld was not charging. It was stated that the handheld would charge for a bit by repositioning the connection to the handheld but it will not stay charging. A week earlier the nurse said that the desk top charging cradle was not charging the handheld so she bypassed the desk top and just used the charger connected to the handheld and she thought it was charging successfully. The nurse noticed on (b)(6) 2012 that it was still not charging. It was later stated that the handheld had been stored appropriately and there was no obvious cause for it no longer charging. The manufacturer's consultant tried her charger with the problematic handheld and the handheld still wouldn't charge. The charging light on the handheld would only turn on when you hold the cable in a certain position. The charging/power adapter cable was reported to be working properly. On (b)(4) 2012 the handheld and flashcard were returned to the manufacturer for product analysis that has not yet been completed.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2012 when product analysis was completed on the handheld and flashcard. An analysis was performed on the returned flashcard and no anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Analysis was performed on the returned handheld and no anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2805800
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« Reply #16 on: December 17, 2018, 03:30:10 AM »

Model Number MODEL 250
Event Date 11/05/2012
Event Type  Malfunction   
Event Description
Follow up with the physician's assistant found that the handheld had been stored in the nurse practitioner's office at normal room temperature and as far as it was known, the handheld had not been exposed to any harsh temperature conditions. Product analysis on the software found no anomalies associated with flashcard software or databases. The flashcard and software performed according to functional specifications. An analysis was performed on the returned handheld and the reported allegation was not verified. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the handheld connector is most likely associated with mishandling of the device as it appears the serial cable connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the handheld pcb and attached cable receptacle. Results of testing demonstrate that both the returned battery and handheld support device communications as expected. The battery charging connector on the bottom of the handheld prevented the battery from being charged. No other anomalies were identified.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2012, the physician's assistant called to report that her handheld computer will not maintain a charge. She stated that she had tried to plug the handheld into three different outlets to confirm if that was the issue and had also performed several hard resets. The pa stated that although she could not visualize any problems with the ac power cable, the handheld sometimes needed to be seated into the power cable connection at a particular angle in order for it to charge properly. The physician's assistant also reported that after unplugging the handheld from the power supply, the power button lights up in red and the computer then shuts off. The product was received on (b)(4) 2012 and is pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2857077
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« Reply #17 on: December 17, 2018, 03:30:57 AM »

Model Number MODEL 250
Event Date 01/17/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
A former company representative's programming system was returned to the manufacturer when they left the company. Product analysis was completed on the wand, handheld and flashcard. No visual or mechanical anomaly was identified with the wand. Continuity testing of the serial data cable and the battery cable passed. The programming wand performed according to functional specifications. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2964161
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« Reply #18 on: December 17, 2018, 03:31:44 AM »

Model Number MODEL 250
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A neurologist reported to our consultant that their handheld computer is no longer able to hold a charge and that he has already tried to plug it into several different wall outlets with the same result. He stated that the ac power cord was checked visually and nothing appeared to be wrong with it. He was not sure when this issue first began but explained that it has been going on for a while. The handheld was returned for analysis. Analysis was performed on the returned handheld. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023379
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« Reply #19 on: December 17, 2018, 03:33:05 AM »

Event Date 04/04/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that a serial cable and two power cables for the handheld were going to be returned to the manufacturer for product analysis. They were received on (b)(6) 2013 and are undergoing product analysis.

Event Description
On (b)(4) 2013 it was reported that the handheld was not holding a charge. Troubleshooting was performed with chargers and connections that were known to be working but the handheld still would not hold a charge. Attempts for the return of the handheld to the manufacturer for product analysis have been made but the handheld has not been returned to the manufacturer to date.

Event Description
Additional information was received when the handheld and flashcard were returned for product analysis. Product analysis on the handheld was completed on (b)(6) 2013. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Product analysis on the flashcard was also completed on (b)(4) 2013. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

Event Description
On (b)(4) 2013 product analysis was completed on the ac power cords. For one of the cords, there were no observed anomalies; returned ac power cradle provided consistent power to the hhd in the pa lab. For the second power cord, product analysis identified that the connector to the ac adapter was damaged, exposing the metal contacts inside. The most likely cause for the damage is associated with mishandling of the cord. Despite the physical connector damage, the ac adapter performed as expected and charged the hhd battery. No other anomalies were identified. Product analysis was also completed on the serial cable. No anomalies were noted during testing; the serial cable performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3078679
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« Reply #20 on: December 17, 2018, 03:34:56 AM »

Model Number MODEL 250
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The handheld device has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative
Type of device name, corrected data: the initial reported inadvertently reported the type of device as the programming software when the issue was with the programming computer.

Event Description
Additional information was received that unless he holds it a certain way, it won't maintain a charge or communicate properly during interrogation. Also, when he attempted to use it on a patient, the hhd kept on shutting down. A "check sum" error appeared on his screen. He said patients¿ vns is working and they feel stimulation. Attempts for product return have been unsuccessful.

Event Description
Our consultant reported that he received a call from a neurology office reporting that their handheld computer only charges a when the ac power adapter is connected a certain way and ¿wiggled around. ¿ he explained that he has to ¿play around with it to get it to charge. ¿ the handheld itself does hold a charge if it charges correctly with the ac power adapter held a certain way. Good faith attempts are underway for further details about the reported event.

Event Description
Analysis of the handheld was completed on (b)(4) 2014. During the analysis, it was identified that the handheld would not power on using a known good ac adapter. The cause for the anomaly is associated with damaged handheld sync connector leads to the pcb. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3126684
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« Reply #21 on: December 29, 2018, 04:12:29 AM »

Model Number MODEL 250
Event Date 11/08/2013
Event Type  Malfunction   
Event Description
It was reported that the company representative's handheld will not hold a charge. A hard reset did not correct the issue. No patients were affected by this. A new programming system was provided to the company representative and the handheld and flashcard were returned for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.
 
Event Description
Analysis of the handheld was completed on (b)(4) 2013. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that some of the sync cable connector leads were damaged and that the solder connections between the sync cable connector leads and the pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was completed on (b)(4) 2013. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3499875
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« Reply #22 on: January 02, 2019, 02:09:53 AM »

Model Number MODEL 250
Event Date 12/11/2013
Event Type  Malfunction   
Event Description
A company representative reported that his handheld will not hold a charge. It was reported that the handheld was charged and then when taken off of the charger it dies shortly after. Troubleshooting was performed by the company representative by adjusting the battery, battery latch and battery cover, but the problem still persisted. A new programming computer was provided to the company employee. The handheld is expected to be returned for analysis, but has not been received to date.
 
Manufacturer Narrative

Event Description
The handheld and flashcard were returned for analysis. The handheld analysis was completed on 04/23/2014. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that some of the sync cable connector leads were damaged and that some of the solder connections between the sync cable connector leads and the handheld pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was completed on 04/23/2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3556014
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« Reply #23 on: January 06, 2019, 03:36:32 AM »

Model Number MODEL 250
Event Date 01/10/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that a programming system was not working due to communication issues. The programming system would work intermittently and the communication difficulties were confirmed on a demo device. The 9v battery was not the cause of the communication issues. The programming system was returned to the manufacturer where the failure to program was confirmed and attributed to an intermittent conductor in the serial data cable. Once the cable was substituted, all communication errors cleared. No issues with the returned flashcard were noted. During analysis of the returned handheld, it was identified that some of the sync cable connector leads were damaged and that the solder connections between the sync cable connector leads and the pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. It was also identified that the serial cable was unable to establish communication using a known good wand and the returned handheld. The cause for the communication difficulties is associated with a broken wire connection on the axim connector plug pcb. Once the wire was soldered back onto the dell axim connector plug pcb, the serial cable was able to establish communication between the handheld and wand. The most likely cause for the wire breaks can be associated with mishandling of the serial cable. The communication errors associated with the intermittent conductor in the wand will be reported via alternate summary reporting.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3632939
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« Reply #24 on: January 12, 2019, 02:11:20 AM »

Model Number MODEL 250
Event Date 03/14/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that nurse¿s handheld device was charging intermittently. The serial cable had to be in a certain position in order for the handheld to charge. The serial cable was swapped but the issue was not resolved. It was reported that no mishandling had occurred. The handheld device was returned to the manufacturer for analysis. Analysis of the returned handheld did not identify any anomalies associated with the main battery. Analysis of the handheld did identify that some of the sync cable connector leads were damaged and that some of the solder connections between the sync cable connector leads and the handheld pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3736888
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« Reply #25 on: January 14, 2019, 03:31:28 AM »

Model Number MODEL 250
Event Date 05/05/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the nurse was having issues with her handheld device. Troubleshooting was performed and it was determined that the power adaptor required specific positioning in order to charge the device properly. The handheld device and power adapter has not been returned to the manufacturer to date.
 
Event Description
The handheld and flashcard were received for analysis. Analysis of the handheld was completed on 07/16/2014. During the analysis it was identified that the handheld would not power on using a known good ac adapter. The cause for the anomaly is associated with damaged handheld sync connector leads to the pcb. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. Analysis of the flashcard was completed on 07/16/2014. An analysis was performed on the returned flashcard and the reported allegation was verified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3841020
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« Reply #26 on: January 15, 2019, 01:31:45 AM »

Model Number MODEL 250
Event Date 04/22/2014
Event Type  Malfunction   
Event Description
It was reported that the serial cable for the handheld device was causing communication and charging issues. The wand battery was replaced and the wand was confirmed to be functioning properly when connected to another handheld device. The handheld device was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the handheld was completed on (b)(4) 2014. During the analysis it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3816172
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« Reply #27 on: January 16, 2019, 01:33:15 AM »

Model Number MODEL 250
Event Date 04/02/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician's handheld is not holding a charge. A new programming tablet was provided to the physician and the handheld was returned to manufacturer for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the handheld was completed on 05/12/2014. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that some of the sync cable connector leads were damaged and that some of the solder connections between the sync cable connector leads and the handheld pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was completed on 05/12/2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3784527
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« Reply #28 on: January 16, 2019, 01:34:07 AM »

Model Number MODEL 250
Event Date 04/07/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution. Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the nurse¿s handheld device had a faulty serial cable that required specific positioning to allow intermittent communication. An analysis was performed on the returned handheld and a likely cause for the reported allegation was identified. During the analysis, it was identified that some of the sync cable connector leads were damaged and the solder connections between the sync cable connector leads and the handheld pcb were cracked. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. An analysis was performed on the returned flashcard. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3786359
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« Reply #29 on: January 18, 2019, 02:41:14 AM »

Model Number MODEL 250
Event Date 05/01/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld was not able to hold a charge and that occasionally the hard reset screen will appear. The physician requested a new programming computer. The handheld and flashcard were returned for analysis. The handheld analysis was completed on (b)(4) 2014. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the handheld would not power on using a known good ac adapter. The cause for the anomaly is associated with damaged handheld sync connector leads to the pcb. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. Additionally, it was identified that handheld was unable to charge the main battery. The cause for the anomaly is associated with broken solder connections on the handheld main board. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3869300
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« Reply #30 on: January 20, 2019, 01:32:26 AM »

Model Number MODEL 250
Event Date 05/09/2014
Event Type  Malfunction   
Event Description
The handheld and flashcard were received for analysis. Analysis of the handheld was completed on (b)(4) 2014. An analysis on the returned handheld found that the device would not power on using a known good ac adapter. The cause for the anomaly is associated with damaged solder connections to the pcb. Because of the damage, the handheld received power from the ac adapter intermittently. The cause for the damage to the solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
It was reported that the nurse¿s handheld device was not working properly. The handheld device was slow and worked intermittently. The programming wand was recently replaced and suspected to be contributing to the reported issues. The handheld device took a long to interrogate some devices but worked well with others. The handheld device sometimes failed to interrogate. Troubleshooting was performed and determined that the handheld device needed to be replaced. The handheld device has not been returned to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3847263
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« Reply #31 on: January 24, 2019, 04:20:28 AM »

Model Number MODEL 250
Event Date 07/31/2014
Event Type  Malfunction   
Event Description
Analysis of the returned handheld device and software flashcard was completed. It was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified with the handheld device. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.
 
Event Description
It was reported that the physician's handheld is not charging. A new programming computer was requested. The physician will be provided a new programming computer and the handheld is expected to be returned for analysis. The handheld has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4044298
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« Reply #32 on: February 07, 2019, 01:16:15 AM »

Model Number MODEL 250
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
Additional information received indicated that the original suspect serial adapter cable was discarded and that the returned serial adapter cable is a different cable. During the analysis of the handheld programmer it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged solder connections between the handheld sync connector and the main pcb. The cause for the damage to the solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. No anomalies associated with the returned serial cable were identified during the analysis. No anomalies were noted with the software flash card. The software performed accordingly to functional specifications.
 
Manufacturer Narrative
Report source, corrected data: the initial report inadvertently indicated a health professional was also a report source. The only report source was the company representative.
 
Event Description
It was reported that the company representative's handheld was not holding a charge after charging. Troubleshooting was performed which identified that the handheld and charging cable had an incomplete connection and that when the connection was reconnected the handheld charged and held the charge appropriately. It was reported that the handheld and cable are touchy at times but the handheld is always able to be connected and charge properly. The company representative was provided a new cable. No additional relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
The handheld computer programmer, software and serial adapter cable were returned to the manufacturer for product analysis on 6/11/2015. The ac power adapter was not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4432294
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« Reply #33 on: February 07, 2019, 01:16:55 AM »

Model Number MODEL 250
Event Date 11/04/2014
Event Type  Malfunction   
Event Description
It was reported that the company representative has experienced difficulty with the handheld's battery life and that while testing the handheld the screen became unresponsive during calibration. A hard reset was performed; however, the screen unresponsiveness continued. The company representative was provided a new programming tablet. The handheld is expected to be returned for analysis, but has not been received to date.
 
Event Description
The handheld and flashcard were received for analysis. Analysis of the handheld was completed on 03/06/2015. No anomalies associated with the handheld display or battery were identified during the analysis. During the analysis it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was completed on 03/10/2015. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4287464
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« Reply #34 on: February 07, 2019, 01:17:40 AM »

Model Number MODEL 250
Event Date 01/05/2015
Event Type  Malfunction   
Event Description
Product analysis was completed on the flashcard on 02/12/2015. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Product analysis was completed on the handheld on 02/12/2015. Non-responsiveness from the handheld was found to be due to a damaged connector receptacle where the serial data cable normally attaches; receptacle became partially separated from the main pcb with some broken connector pins; most likely associated with wear or excessive cable manipulation. During the analysis on the handheld it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with bad solder connections between the sync connector and the main pcb. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached sync connector. No other anomalies were identified.
 
Manufacturer Narrative
 
Event Description
It was reported that the serial cable connection to the handheld was loose. It was verified that the issue was with the handheld as the serial cable functioned fine with another handheld. Another serial cable was tried with the handheld and it was also found to be loose in the handheld. The handheld and flashcard were returned for product analysis on 01/27/2015. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4460625
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« Reply #35 on: February 11, 2019, 01:21:02 AM »

Model Number MODEL 250
Event Date 01/14/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the handheld¿s serial cable needed to be manipulated in order to work. A new serial cable was tried and the physician still had to ¿wiggle¿ the cable to get it to work, therefore it was believed the issue is with the handheld. The old serial cable worked fine with another programming system. Attempts have been made for product return but it has not been received to date.
 
Event Description
On 03/06/2015 product analysis was completed on the serial cable. No anomalies associated with the serial cable were noted during testing. The serial cable performed according to functional specifications. Product analysis was completed on the handheld on 03/18/2015. During the analysis it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Product analysis was also completed on the flashcard. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
On (b)(46) 2015 the serial cable was returned for product analysis. On (b)(6) 2015 the handheld and flashcard were returned for product analysis. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4491144
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« Reply #36 on: February 13, 2019, 01:22:42 AM »

Model Number MODEL 250
Event Date 01/26/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the handheld may have gotten ¿zapped¿.
 
Manufacturer Narrative
 
Event Description
It was reported that the physician was having difficulty turning on the programming handheld. The screen lock button, the battery latch, and the wall outlet were all checked, which did not resolve the issue. A soft reset was performed but the handheld only flashed the red light on the power button and nothing appeared on the screen. A hard reset only resulted in a ¿¿battery critically low¿ message appearing on the screen. The office had another programming handheld and when they tried to plug that one into the power cable of the first programming handheld, there was an inability to charge that one as well. It was therefore believed that the issue may be with the power cable and a new power cable was sent to the physician, but this did not resolve the issue with the programming handheld not turning on. It was reported that the programming handheld would be returned for product analysis but it has not been received to date.
 
Event Description
The handheld and flashcard were received for analysis. Analysis of the handheld was completed on (b)(4) 2015. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was completed on (b)(4) 2015. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4524519
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dennis100
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« Reply #37 on: February 14, 2019, 01:27:08 AM »

Model Number MODEL 250
Event Date 02/25/2015
Event Type  Malfunction   
Event Description
Product analysis was completed for the handheld device on (b)(6) 2015. No anomalies associated with either of the 2 returned ac adapters were identified during the analysis. During the analysis it was identified that the handheld would not power on. The cause for the anomaly is associated with damaged handheld sync connector leads to the main pcb. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Product analysis was completed for the software flashcard on (b)(4) 2015. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
A company representative reported that there is an issue with the handheld power cable port, which is preventing the handheld from charging. It was reported that the cable worked in other handhelds and that other cables produced the same result. A new programming tablet was provided to the company representative. The faulty handheld is expected to be returned for analysis, but has not been received to date.
 
Manufacturer Narrative

Event Description
The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4632858
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dennis100
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« Reply #38 on: February 16, 2019, 01:42:00 AM »

Model Number MODEL 250
Event Date 02/09/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician's handheld charging cable is loose and a fault message was received. The physician was provided a new programming tablet. The handheld and cables were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Product analysis was completed for the handheld device. During the analysis, it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged sync connector leads and broken sync connector solder connections to the pcb. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Product analysis was completed for the software flashcard. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4586145
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dennis100
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« Reply #39 on: February 23, 2019, 02:05:09 AM »

Model Number MODEL 250
Event Date 03/02/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The handheld and programming software were returned for analysis on 04/16/2015. Product analysis was completed on the flashcard on 05/06/2015. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Product analysis was completed on the handheld on 05/06/2015. During the analysis it was verified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged sync connector leads on the main pcb. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified.
 
Event Description
It was reported that the physician's handheld was fully charged, but would not power on. The unlock button was identified to not be engaged and the battery was removed and replaced; however, this did not resolve the issue. The physician was provided a new programming computer. The handheld is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4650422
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dennis100
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« Reply #40 on: February 28, 2019, 03:06:13 AM »

Model Number MODEL 250
Event Date 05/01/2015
Event Type  Malfunction   
Event Description
It was reported the nurse the hand held device does not work. The vns representative performed trouble shooting which showed that the hand held device was unable to be turned on, even when charged. The suspected hand held device was received on 06/29/2015. However, analysis has not been completed to date.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis for the hand held device was completed and showed that no anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the hand held device would not power on using the ac adapter. The cause for the anomaly is associated with damaged solder connections between the sync connector and the main board. Because of the damage, the hand held device was unable to receive power from the ad adapter. The cause for the damage to the solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified with the hand held device. Product analysis for the software and flashcard was completed showing no anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4878479
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dennis100
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« Reply #41 on: March 11, 2019, 07:17:48 AM »

Model Number MODEL 250
Device Problem Premature Discharge of Battery
Event Date 08/24/2015
Event Type  Malfunction   
Event Description
It was reported that the handheld computer's battery did not keep the charge long enough once it was unplugged from the outlet. Review of manufacturing records confirmed that the handheld passed all functional tests prior to distribution. The suspect handheld computer was received by the manufacturer. Analysis is underway but it has not been completed to date.
 
Event Description
Analysis of the returned handheld was completed and it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. During the analysis, it was identified that handheld was unable to charge the main battery. The cause for the anomaly is associated with broken solder connections on the handheld main board. No anomalies associated with the main battery were identified during the analysis. No other anomalies were identified. An analysis was performed on the returned flashcard and no anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5086605
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dennis100
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« Reply #42 on: March 15, 2019, 12:48:30 AM »

Model Number MODEL 250
Device Problems Failure to Charge; Handpiece
Event Date 09/28/2015
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld will not maintain a charge and it powers down as soon as it is unplugged. The handheld and flashcard were returned for product analysis on (b)(6) 2015. Product analysis is currently underway and has not yet been completed.
 
Event Description
Product analysis was completed on the handheld and flashcard on 11/05/15. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5173881
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dennis100
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« Reply #43 on: March 15, 2019, 12:49:16 AM »

Model Number MODEL 250
Device Problems Connection Problem; Handpiece
Event Date 09/17/2015
Event Type  Malfunction   
Event Description
It was reported that a company representative was having difficulties to use her programming system. It was reported that the handheld computer was not functioning properly due to a suspected connection issue with the serial cable. The handheld was returned to the manufacturer on (b)(6) 2015. Analysis is underway but it has not been completed to date.
 
Event Description
Analysis of the returned handheld was completed. No anomalies associated with the returned x50 serial cable were identified during the analysis. During the analysis, it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly is associated with damaged leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. The non-responsiveness from hhd is due to a damaged connector receptacle where the serial data cable normally attaches; receptacle became partially separated from the main pcb with some broken connector pins; most likely associated with wear or excessive cable manipulation. Analysis of the returned flash card was completed and no anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5146713
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dennis100
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« Reply #44 on: March 27, 2019, 01:06:14 AM »

Model Number MODEL 250
Device Problem Failure to Charge
Event Date 12/07/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by a psychiatrist that her programmer would not hold a charge. The programmer was kept plugged in and charging for two weeks prior to the report. The device was able to power on. The available data could be cleared successfully when prompted. The device would power down after reaching the alignment screen. The battery cover was verified to be closed and locked. The charging indicator was flashing red. The handheld was unplugged and plugged back in again. The device was powered back on again and would turn off after reaching the alignment screen. The suspect device has not been received to-date. No additional relevant information has been received to-date.
 
Event Description
A company representative visited the site and attempted troubleshooting. A hard reset was unsuccessful. The company representative tried removing and re-inserting the battery and this also did not resolve the issue. The programmer and software were received by the manufacturer where analysis is underway, but has not been completed to-date.
 
Event Description
Analysis was completed on the returned handheld. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the handheld would not power on using the ac adapter. The cause for the anomaly was associated with damaged solder connections associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the solder connections is most likely associated with mishandling of the device as it appears the connector detents were not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the printed circuit board and attached cable receptacle. During the analysis, it was also identified that the handheld was unable to charge the main battery. The cause for the anomaly is associated with broken solder connections on the handheld main board. The battery terminal was soldered onto the handheld main board, and the main battery was fully recharged successfully using the power supply adapter. No other anomalies were identified. Analysis was performed on the flashcard. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5345464
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