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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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