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dennis100
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« Reply #30 on: February 04, 2017, 03:32:10 AM »

Model Number 250
Event Date 07/12/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that her programming system was not operating properly, as it would not communicate with patients' vns therapy pulse generators. Programming handheld was subsequently returned to manufacturer for product analysis. An analysis was performed on the handheld and it was identified that the ac adapter was damaged and no longer able to provide consistent power to the handheld. Once a known good ac adapter was used, no anomalies with the device performance were noted during testing using ac adapter or the main battery with a full charge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=891275
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« Reply #31 on: February 05, 2017, 01:47:46 AM »

Model Number MODEL 250
Event Date 06/01/2007
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Rptr indicated that a hp handheld computer had a loose ac adapter connection and the handheld would not power on.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=881177
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dennis100
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« Reply #32 on: February 05, 2017, 01:48:34 AM »

Model Number MODEL 250
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that the site's hp handheld computer battery was not holding a charge. It was also reported that the ac adapter power cord appeared to be damaged. A new handheld was sent to the site.

Manufacturer Narrative
Device failure is suspected, 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=871763
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« Reply #33 on: February 05, 2017, 01:49:38 AM »

Model Number MODEL 250
Event Date 05/23/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the handheld battery was dead and would not charge when it was plugged into the ac adapter. The ac adapter was making a loose connection with the handheld and one of the gold prongs on the ac adapter had fallen off. A replacement was sent to the site. The handheld was returned to manufacturer. Product analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=868596
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dennis100
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« Reply #34 on: February 05, 2017, 01:51:23 AM »

Model Number MODEL 250
Event Date 04/19/2007
Event Type Malfunction
Event Description
Reporter indicated that hp jornada handheld computer had a bad connection where the ac adapter connects to it. It is not making a proper connection and the power button did not come on. Product analysis on the handheld revealed that the support tab of the terminals in the ac adapter connector was broken and that one of the terminals was bent, which would prevent a proper connection. These conditions were most likely the result of the force exerted by user handling.

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=852320
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dennis100
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« Reply #35 on: August 02, 2017, 12:11:26 AM »

Model Number 250
Event Date 06/29/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the physician was having issues communicating with a pt's generator and was receiving the error message "there is an error establishing communication with the device, try repositioning the wand". They repositioned the wand, replaced the 9v battery and checked all connections but was still unsuccessful with communicating with the generator. The pt was taken to a different room and was able to be interrogated and it was confirmed that the pt was not at end of service. However, the error message was received again when diagnostics were attempted. The office was eventually able to perform a final interrogation to confirm the pt was at intended settings. Additional info came in indicating that the handheld was not charging. The indicator light would be red if she held the cord but would go off when the cord was released. A new handheld was sent to the site and they were able to use it successfully with their current wand. The handheld and flashcard were returned to the mfr for eval. No anomalies associated with the handheld serial cable were noted during testing. During the analysis, it was identified that the ac adaptor was defective and unable to supply power to the handheld. No further anomalies were identified using a known good ac adapter. 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=2199164
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dennis100
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« Reply #36 on: August 10, 2017, 07:12:29 AM »

Model Number MODEL 250
Event Date 08/31/2011
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the physician's handheld would not hold a charge, even when left plugged in overnight. The handheld would power on while plugged in; however once it was removed from the wall, the handheld would not come on. The handheld is normally stored at room temperature in the physician's office. The device has not yet been returned to the manufacturer for product analysis.
 
Event Description
The handheld and flashcard were returned to the manufacturer for analysis and analysis has been completed. An analysis was performed on the returned flashcard. No anomalies associated with flashcard software or databases were identified during the analysis. The flashcard and software performed according to functional specifications. An analysis was performed on the returned handheld. No anomalies associated with the handheld performance were noted during testing using a known good a/c adapter or the main battery with a full charge. The handheld performed according to functional specifications. It was noted during product analysis that the a/c adapter for the handheld device was not returned with the handheld; therefore proper function of the a/c adapter cannot be confirmed and a device issue cannot be completely ruled out. Attempts for the return of the a/c adapter have been unsuccessful to date.
 
Manufacturer Narrative
While proper function of the handheld device was confirmed, a device charging issue cannot be ruled out as the a/c adapter for the handheld was not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2263580
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dennis100
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« Reply #37 on: August 29, 2017, 12:43:56 AM »

Model Number MODEL 250
Event Date 11/01/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was initially reported that the physician's handheld would not turn on. The handled was reported to be fully charged and plugged in, but would not turn on. The physician declined to perform troubleshooting. The wand, handheld and flashcard were returned to the manufacturer for evaluation. Product analysis is planned, but has not been completed.
 
Event Description
Additional information was received that product analysis was complete 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. The handheld was able to power on and off during testing with no observed anomalies. During the analysis it was identified that the ac adapter was no longer able to provide power to the handheld. A root cause for the ac adapter failure could not be identified during the analysis. 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 was found, 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=2384812
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dennis100
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« Reply #38 on: August 29, 2017, 12:44:55 AM »

Model Number MODEL 250
Event Date 11/16/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Reporter indicated that a charger power cord for a vns (b)(4) x50 computer was not charging the computer. The power cord ac adapter was returned for analysis. An analysis was performed on the returned ac adapter and the reported allegation was verified. The cause for the reported complaint is associated with a defective 120v ac power cord. Continuity testing of the cord identified that both wire connections were open. A root cause for the open wire connections could not be identified during the analysis. No further anomalies associated with the ac adapter were identified using a known good 120v power cord.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2377525
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dennis100
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« Reply #39 on: September 06, 2017, 08:14:06 AM »

Model Number MODEL 250
Event Date 01/03/2012
Event Type  Malfunction   
Event Description
Analysis was completed of the returned handheld. Analysis of the handheld revealed that during the analysis it was identified that handheld was unable to charge the main battery. The primary cause for the anomaly is associated with broken solder connections on the handheld main board. Additionally, it was identified that the returned ac adapter and cradle were unable to power and charge the returned handheld. The cause for the anomaly is associated with an incompatible aftermarket ac adapter. No further anomalies were identified. Moreover analysis of the flashcard indicated that 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.
 
Event Description
It was initially reported by a neurologist that his handheld computer could not be recharged due to unknown reason. There was no user mishandling reported to have contributed to the event. A new handheld was provided to the physician and the reported handheld was returned to the manufacturer for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2435359
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dennis100
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« Reply #40 on: September 12, 2017, 12:02:59 AM »

Model Number MODEL 250
Event Date 03/16/2012
Event Type  Malfunction   
Event Description
It was initially reported by a nurse that, when she plugged the handheld into the wall outlet on (b)(6) 2012, the handheld did not appear to be charging and was at 50% battery life. She then exchanged the ac power cord with the cord from a different handheld and plugged it in to the same wall outlet. The handheld started charging correctly; becoming fully charged after about 20 minutes. A replacement power cord was requested and the old ac adapter was returned for product analysis. Analysis was completed on (b)(4) 2012. An analysis was performed on the returned ac adapter. During the analysis the ac adapter was utilized in an attempt to power a known good handheld device; however this was unsuccessful. The power button did not indicate that the handheld was receiving power from the ac adapter. The cause for the reported complaint is associated with a defective power supply module; however the cause of the defect could not be determined during the analysis.
 
Manufacturer Narrative

Event Description
Further analysis of the power supply, completed on (b)(6) 2012, identified that the most likely cause for the power supply failure is associated with a component failure caused by the contamination of an unknown green substance that was identified inside the case, on the pcb, and on the power supply components.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2529946

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dennis100
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« Reply #41 on: January 10, 2018, 01:23:29 AM »

Model Number 250
Event Date 01/01/2009
Event Type Malfunction
Event Description
Neurosurgeon reported that the adapter cord connecting the dell axim handheld computer and the programming wand was broken. A new handheld was sent to the neurosurgeon and the previously used handheld was returned to the mfr. At this time, the handheld and its components are undergoing product analysis.

Manufacturer Narrative
Device failure is suspected, 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=1455830
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dennis100
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« Reply #42 on: March 12, 2018, 12:20:58 AM »

Model Number MODEL 250
Event Date 06/20/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
An analysis was performed on the returned handheld. During the analysis it was identified that the ac adapter was defective and could no longer power the handheld. No further anomalies associated with the handheld performance were noted during testing using a known good ac adapter or the main battery with a full charge. When analysis of the software was performed it was identified that the flashcard contained a non-vns file and non-vns folders. The file and folders were created as a result of the flashcard being inserted into a (b)(6) computer. The file and folders had no impact on the vns and flashcard performance. 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 malfunction occurred but did not cause or contribute to a death or serious injury.

Event Description
It was reported by a company representative that a physician's handheld computer no longer worked. Additionally, the area representative indicated he used his programming wand with the reported handheld and communication was unsuccessful with a vns patient. The reported handheld was returned to the manufacturer and at the moment remains under analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2653531
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dennis100
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« Reply #43 on: March 18, 2018, 12:27:03 AM »

Model Number MODEL 250
Event Date 10/03/2012
Event Type Malfunction
Event Description
Additional analysis was performed on the returned ac adapter. The returned ac adapter was opened to perform a visual inspection of the internal components and printed circuit board. Results of the visual inspection identified no anomalies. No further analysis could be performed as this is a non-cyberonics manufactured product and no additional product information is available.

Event Description
Reporter indicated a vns dell x50 computer would not power on. The computer used to power on but would take 10-15 minutes to do so. Now, it does not power up at all. A hard reset of the computer did not resolve the issue, and it was confirmed the "lock" button was not engaged. The computer, flashcard, and programming wand were returned for analysis. No anomalies were noted with the programming wand or flashcard. No anomalies associated with the main battery of the computer were identified during the analysis. During the analysis it was identified that the returned ac adapter was defective and unable to power the returned handheld. The cause for the anomaly is associated with an incompatible (underrated) ac adapter. No further anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2804113
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« Reply #44 on: April 28, 2018, 12:21:44 AM »

Model Number MODEL 250
Event Date 05/21/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that the handheld was not charging properly. It was stated that the power cord was found to be the problem as the handheld worked fine with an alternative charger. It was stated that the wand and cable adapter are all fine. The nurse said she had dropped the power cord and it hit the floor at the ¿part of the box which connects both the wires¿; since that time it has not worked. When it is connected to the handheld and plugged in there is no charging light at all. It was stated that the device would be returned to the manufacturer for product analysis but it has not been received to date.
 
Manufacturer Narrative

Event Description
It was reported that the device would be returned for product analysis but it appears to have been lost in the mail as it was reported to have been sent but it was not received by the manufacturer for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167335
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dennis100
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« Reply #45 on: July 25, 2018, 05:48:02 AM »

Model Number 250
Event Date 11/01/2010
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 power cable on a physician's hp jornada handheld device was not making a good connection with the handheld; therefore, the handheld could not charge fully. A replacement handheld and power cable was sent to the physician and the hp jornada and power cable in question were returned to the manufacturer for analysis. During the analysis oft he handheld, it was identified that the connector to the handheld device was damaged and the ac adapter could no longer charge the main battery. No other anomalies on the device performance were noted during testing using a known good ac adapter or the main battery with a full charge. 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=1931687
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« Reply #46 on: October 13, 2018, 04:25:38 AM »

Model Number MODEL 250
Event Date 06/15/2012
Event Type  Malfunction   
Event Description
A vns consultant was at a clinic, and it was reported that their handheld computer was not holding a charge. The consultant could not get the handheld computer to turn on even with it plugged in. It was verified that the lock button was not on, and that a hard reset did not bring up the screen. The programming system is kept in the normal office environment temperature. The handheld was returned, and analysis is pending completion.
 
Manufacturer Narrative

Event Description
The handheld computer was received with a v8. 0 flashcard and with the main battery depleted. The handheld was received without an ac adapter and serial cable. The handheld device was powered using a known good ac power supply with no anomalies from inhouse. The handheld's main battery was fully recharged successfully using the power supply adapter from inhouse. The power button light on the handheld computer was amber and then later turned green giving the indication that the main battery was fully charged. The back-up battery indicator read "normal". This is an indication that the backup battery also was recharged successfully. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. It is likely that their was an issue with the ac adapter cord charging the handheld at the office. The cord was discarded, therefore will not be returned for analysis.
 
Manufacturer Narrative
Event likely related to discarded ac adapter cord failure. Device malfunction suspected with ac adapter cord that was not returned and discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2640276
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« Reply #47 on: October 19, 2018, 11:12:35 AM »

Model Number MODEL 250
Event Date 08/02/2012
Event Type  Malfunction   
Event Description
Product analysis was completed for both the handheld computer and related software. The ac adapter was not returned for analysis. 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. Also during the analysis it was identified that the main battery was inserted backwards. This anomaly can also prevent the handheld from charging the main battery. No further 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.
 
Event Description
It was initially reported on (b)(6) 2012 that the physician's ac power cord for the dell x50 handheld computer was damaged due to somebody inadvertently slamming the cord in a drawer. It became frayed and exposed, so they requested a replacement ac power cord/adapter. The company representative confirmed that the damage was due to the site's handling and they were not alleging a device malfunction. A replacement was provided, but later on (b)(6) 2012, it was reported that the computer would not charge. It was initially thought it was a power cord issue, however even with the power cord, the handheld would not charge and thus the battery was depleted. A replacement handheld computer was provided to the site, and the troubled computer was returned to the manufacturer for product analysis. No mishandling was suspected, and the programming system is stored at room temperature in the provided nylon sack plugged into the ac power outlet. Product analysis has not been completed to date on the returned computer and related software. It was noted upon receiving that the battery was inserted backwards into the computer.
 
Manufacturer Narrative

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=2746945
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« Reply #48 on: March 18, 2019, 01:31:16 AM »

Model Number MODEL 250
Device Problems Failure to Interrogate ; Failure to Power Up
Event Date 08/31/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015, it was reported that the physician's handheld will not turn on despite being plugged into a known to be working outlet. The problem was noted to have begun two weeks prior and multiple patients were unable to be interrogated. The handheld and flashcard were returned for product analysis on (b)(4) 2015. Product analysis is still underway and has not yet been completed.
 
Event Description
On (b)(6) 2015 product analysis was completed on the handheld and flashcard. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the serial cable was providing power to the handheld intermittently. The cause for the anomaly is associated with an open electrical connection in the power cable portion. As a result of the open wire connection, the handheld would receive power from the ac adapter intermittently. 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=5137698
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« Reply #49 on: March 21, 2019, 12:26:15 AM »

Model Number MODEL 250
Device Problem Premature Discharge of Battery
Event Date 10/09/2015
Event Type  Malfunction   
Event Description
It was reported that the handheld's battery would not hold a charge. The handheld has been received for analysis, which is underway but has not been completed to-date. No additional information has been received to-date.
 
Event Description
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 ac adapter was damaged and unable to power the handheld. The cause of the damage was associated with mishandling of the device. No further anomalies were identified. An analysis was performed on the returned flashcard and no anomalies associated with the flashcard software or databases were identified during the analysis. The flashcard and software performed according to specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5202415
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« Reply #50 on: April 03, 2019, 12:48:54 AM »

Model Number MODEL 250
Event Date 04/11/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the physician's handheld device will not power on. This occurs whether or not the device's charging cable is plugged in. No additional pertinent information has been received to date.
 
Event Description
The suspect handheld device and associated flashcard were received by the manufacturer on 05/05/2016, and product analysis was subsequently completed. For the returned handheld, visual inspection of the device showed that the screen was cracked. Additionally, the lock button was in the locked position, thus the initial attempt to power on the handheld was unsuccessful. The lock button was moved to the unlocked position, and the device was successfully powered on. An attempt to advance past the welcome screen was performed but was unsuccessful, as the touchscreen was unresponsive. The cracked screen was replaced with a known good screen, and the initial setup process was performed. No further issues were noted with device charging, generator interrogations or diagnostics. The cause of the cracked screen was mechanical stress. The analysis performed on the returned flashcard showed no identified issues. 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
Describe event or problem, corrected data: follow-up report #1 inadvertently omitted section of product analysis results that pertained to portions of device not returned.
 
Event Description
Further review of product analysis results revealed that the ac adapter cable was not returned with the handheld. As product analysis was not completed on this portion of the device, the possibility the failure to power on was from an issue with the power cord could not be eliminated. Follow up with the physician's office indicated that the power cable could not be located and returned to the manufacturer for product analysis. It has not been returned to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5626315
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« Reply #51 on: April 03, 2019, 12:49:34 AM »

Model Number MODEL 250
Event Date 04/11/2016
Event Type  Malfunction   
Event Description
It was reported that company representative's tablet is faulty. The tablet didn't turn on despite good charging of the device battery, other tablet with was connected with his own wand and usb white cable and the programming system worked fine. It was also reported that no switch on of the tablet is possible also when it is plugged into the wall outlet. The review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution. The return of the suspect tablet is expected but it has not been received to date.
 
Manufacturer Narrative
Date when the manufacturer's employee was aware about the event; corrected data: the previously submitted mdr inadvertently provided an incorrect initial aware date.
 
Event Description
The suspected tablet was returned to the manufacturer on 05/19/2016. An analysis was performed on the returned tablet and the reported allegation was not verified. No anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge. The tablet performed according to functional specifications.
 
Event Description
It was noted during the analysis of the returned tablet that the main battery depleted; therefore the ac power adapter was suspected to be faulty. Attempts to the user, to return the ac power adapter, were unsuccessful. It was reported that suspected adapter was discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5643645
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« Reply #52 on: April 11, 2019, 01:57:18 AM »

Model Number MODEL 250
Event Date 06/22/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that a physician's tablet was not charging with the charger. The company representative used her charger with the physician's tablet, and the tablet charged properly. The company representative was the one to identify that the tablet was not charging. She also tried using a different outlet with the charger, but it did not resolve the issue. The tablet has not been received to date.
 
Event Description
The ac adapter was received on 07/26/2016. Analysis was approved on 08/18/2016. Analysis of the returned ac adapter verified that it was no longer able to power a known good tablet. The cause for the device failure could not be determined during the analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5801596
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