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dennis100
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« Reply #210 on: May 02, 2018, 01:00:11 AM »

Model Number MODEL 250
Event Date 06/13/2013
Event Type  Malfunction   
Event Description
Product analysis of the handheld and flashcard was completed. No software anomalies were identified during the analysis of the handheld. During the analysis it was identified that the touchscreen display was unresponsive. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. An analysis was performed on the returned flashcard and no anomalies associated with flashcard software or databases were identified. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative

Event Description
On (b)(4) 2013, the physician reported that he was having problems with his handheld. Troubleshooting was performed; however, the issue did not resolve. Troubleshooting was again performed on (b)(6) 2013; however, the physician was unable to get the handheld to move past the align screen. Multiple hard resets were performed, but this did not resolve the issue. It was noted that the office was hit by lightening on (b)(6) 2013, and since then, many of the physician's electronic hardware has not been working. The physician lost three computers to the incident. The handheld was plugged into the wall at the time of the lightening strike. No patient's were affected by this issue. The programming system has been returned and is pending product analysis.
 
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=3244985
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dennis100
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« Reply #211 on: May 04, 2018, 12:36:53 AM »

Model Number MODEL 250
Event Date 08/02/2013
Event Type  Malfunction   
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 and software were completed on (b)(4) 2013. No software anomalies were identified during the analysis. During the analysis it was identified that the handheld was unable to advance past the screen alignment utility. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were 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.
 
Event Description
It was reported that the physician's handheld will not go past the first screen where it says to tap the screen. A hard reset was performed which did not resolve the issue. The lock button was not engaged and it was reported that the handheld is charged all of the time; however, the green light is not showing at the top of the handheld. It was reported that the serial cord was not loose. A new handheld was provided to the physician's office. The handheld and flashcard were returned to device manufacturer for analysis on (b)(4) 2013. The returned product form indicated that the handheld was returned due to "not working - frozen". Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3311465
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dennis100
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« Reply #212 on: May 04, 2018, 12:37:29 AM »

Model Number MODEL 250
Event Date 08/04/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On (b)(6) 2013, the physician reported that he could not do anything with the handheld when trying to interrogate patients. He stated that they had tried to restart the handheld "doing all kinds of tricks". After performing a hard reset, they came to a screen and were asked to "tap the screen". When tapping the screen nothing happened and another hard reset was performed. At this second attempt, the site was able to get to the alignment screen; however, there was no response from the handheld when tapping the screen. It was confirmed that the handheld was unlocked. Attempts are being made for the return of the handheld; however, it has not yet been returned. No additional information has been provided.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The programming system was returned and product analysis was performed. During the analysis it was identified that the handheld was unable to advance past the welcome screen. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. No anomalies associated with flashcard software or databases were identified. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3317740
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dennis100
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« Reply #213 on: May 04, 2018, 11:30:05 PM »

Model Number MODEL 250
Event Date 07/31/2013
Event Type  Malfunction   
Event Description
Product analysis was completed on the handheld. No software anomalies were identified during the analysis. During the analysis it was identified that the handheld was unable to advance past the screen alignment utility. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis.
 
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported by the physician that his handheld was not working that morning. The device was frozen at the time stamp screen and a hard reset was performed which resolved the issue. However, as the device was going through the set up process, it became stuck in a loop at the screen alignment screen. A hard reset was performed another 5 times; however, it did not resolve the issue. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the suspect device passed all functional tests prior to distribution. The device was returned on (b)(6) 2013 and is pending product analysis. No additional information has been provided.
 
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=3309182
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dennis100
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« Reply #214 on: May 06, 2018, 12:50:37 AM »

Model Number MODEL 250
Event Date 07/15/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 information was received from the reporter that the physician was experiencing problems with his handheld computer, such that when the computer was charged and attempted to be turned on that it wouldn¿t go past the screen that first appears prompting for the screen to be tapped. The physician tried to turn off the handheld computer but that would not work either. No patients were involved with the reported issue with the handheld computer. The physician¿s site was instructed to troubleshoot the handheld computer by forcing it to go to the align screen, however the computer did not respond. Another hard reset was performed, but the computer became stuck on the tap screen to set up screen again. The screen lock button was not on. As the computer was unable to move past the initial screen, the handheld computer was returned along with the software flashcard to the manufacturer for product analysis on (b)(6) 2013. Analysis of the handheld was completed on 08/01/2013. No software anomalies were identified during the analysis. During the analysis it was identified that the touchscreen display was unresponsive. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. Analysis of the flashcard was completed on 08/01/2013. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications as evaluated through 38-0004-3700.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the handheld computer passed all functional tests prior to distribution. 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=3282943
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dennis100
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« Reply #215 on: May 06, 2018, 12:51:39 AM »

Model Number MODEL 250
Event Date 07/22/2013
Event Type  Malfunction   
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
Additional information was received that product analysis was completed on the handheld and flashcard. During analysis it was identified that the handheld computer was unable to advance past the screen alignment utility. The cause for the anomaly is associated with the resistance values being higher than expected in the touch screen circuitry. The display flex cable to display pcb attachment point appears to be the issue as applied pressure to cable/pcb interface re-established the required continuity and also display functionality. No further anomalies associated with the handheld computer performance were identified during the analysis. Analysis performed on the returned flashcard determined that the allegation of no malfunction suspected/identified 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
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Description of event, corrected data: the initial emdr event description inadvertantly did not indicate the troubleshooting information.
 
Event Description
Per the return product form, the programming system was returned due to the device not responding and freezing. A hard boot, reset, and removal of battery and software disk was performed to troubleshoot.
 
Event Description
It was reported that the physician's handheld would not go past the home screen. Troubleshooting was performed and it was discovered that the lock button was engaged. The handheld screen was unlocked; however, the screen still would not respond. A hard reset was performed; however, the handheld would now not go past the align screen. The screen was cleaned; however, this did not resolve the issue. A new handheld was provided to the physician's office and the frozen handheld was returned to manufacturer for analysis. Product analysis is underway; however, has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3287172
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dennis100
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« Reply #216 on: May 06, 2018, 12:52:14 AM »

Model Number MODEL 250
Event Date 07/23/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that the physician's handheld was not responding to touches of the screen. The following troubleshooting was performed: hard reset, removed and reinserted flash card, removed and reinserted battery, confirmed handheld was not locked. However, the issue was not resolved. It appeared that the time was still working on the screen; however, the device would not respond to touch. Another hard reset was performed and the physician was able to get to the alignment screen; however, the screen would not respond to the tap of the stylus. The physician wiped the screen with a dry cloth and tried to clean the crevice around the screen; however, this did not solve the issue. No patients were affected. Review of the manufacturing records for the handheld confirmed the handheld met all final testing specifications prior to distribution. The handheld and software were returned to the manufacturer and are pending product analysis.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that product analysis was completed on the handheld and flashcard. An analysis was performed on the returned handheld and the reported allegation was verified. During the analysis, it was verified that the touchscreen display was unresponsive. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3291606
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dennis100
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« Reply #217 on: May 06, 2018, 12:52:54 AM »

Model Number MODEL 250
Event Date 06/11/2013
Event Type  Malfunction   
Event Description
The handheld device and software flashcard were returned on (b)(6) 2013 and are pending analysis.
 
Manufacturer Narrative
Serial #, corrected data: previously submitted mdr included an incorrect serial number for the suspect medical device. This report is being submitted to correct this information. Manufacture date, corrected data: previously submitted mdr included an incorrect manufacture date for the suspect medical device. This report is being submitted to correct this information.
 
Event Description
On (b)(6) 2013, it was reported that a handheld device was continually freezing, this was typically resolved with a hard reset, but now the touch screen no longer responds either. Attempts for additional information have been unsuccessful. The product has not been returned to date.
 
Manufacturer Narrative

Event Description
The handheld analysis was completed on (b)(6) 2013. During the analysis it was identified that the handheld could not complete the screen alignment utility during the initial setup process. The cause for the anomaly is associated with debris that was trapped under the case. Once the display was cleaned, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. 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=3200392
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dennis100
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« Reply #218 on: May 07, 2018, 12:12:22 AM »

Model Number MODEL 250
Event Date 07/19/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause of contribute to a death or serious injury.
 
Event Description
It was reported that the physician's handheld would not power on. A company representative went to the site to troubleshoot the handheld. A hard reset was performed and the handheld was able to be powered on. The handheld then became frozen on the screen alignment which did not resolve despite multiple hard resets. The handheld and flashcard were returned to manufacturer for analysis. Analysis of the handheld was completed on (b)(6) 2013. No software anomalies were identified during the analysis. During the analysis it was identified that the handheld was unable to advance past the screen alignment utility. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. Analysis of the flashcard was completed on (b)(6) 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=3285543
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dennis100
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« Reply #219 on: May 07, 2018, 12:12:59 AM »

Model Number MODEL 250
Event Date 07/09/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 information was received from the reporter stating that the physician¿s handheld computer was stuck at the align screen. A hard reset was performed twice and both times the handheld computer stayed at the align screen and was otherwise unresponsive. Any other troubleshooting procedures could not be performed. A replacement handheld computer was shipped to the physician and the handheld computer in question has been received by the manufacturer, along with its flashcard, for product analysis. Analysis of the handheld is underway; however, has not yet been completed to date.
 
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
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the handheld passed all functional tests prior to distribution. Product analysis was performed on the returned handheld, which confirmed defective display screen. Following replacement with a known good screen, full product functionality was restored. An analysis was performed on the returned handheld and the reported allegation was verified. During the analysis it was identified that the touchscreen display was unresponsive. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. 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. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3261052
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dennis100
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« Reply #220 on: May 09, 2018, 12:36:55 AM »

Model Number MODEL 250
Event Date 09/23/2013
Event Type  Malfunction   
Event Description
The handheld and flashcard was received for analysis. Analysis of the handheld was completed on (b)(4) 2014. A visual analysis of the handheld was able to confirm that the display was cracked. The cause for the cracked screen is associated with mishandling of the device. Once the screen was replaced with a known good screen, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. 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 manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.
 
Event Description
It was reported that the handheld screen cracked when the user pushed down on the bottom left corner with the stylus. The handheld is expected to be returned for analysis; however, has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3420717
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dennis100
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« Reply #221 on: May 10, 2018, 12:21:36 AM »

Model Number MODEL 250
Event Date 09/05/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, the physician reported that the handheld was stuck at the tap screen at the initial screen. The physician said that the handheld was not responding to the screen taps. After performing a heard reset, the physician said that the handheld was stuck on the first screen that says to tap the screen (the "alignment screen"). Despite multiple hard resets, they were unable to go past this screen. The physician tried to hold the top and bottom buttons together; however, this had no response as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3384974
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dennis100
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« Reply #222 on: May 12, 2018, 12:46:25 AM »

Model Number MODEL 250
Event Date 10/09/2013
Event Type  Malfunction   
Event Description
On (b)(6), 2013, it was reported that the physician's handheld was not working properly. A soft reset was performed; however, it did not resolve the issue. It was reported that while trying to interrogate, the programming system keeps saying the interrogation is successful; however, the parameters do not appear. After performing a hard reset, the issue was resolved. Interrogation was tried again and it was verified that it was working, but this time a failure to receive all bytes message appeared. The wand battery was changed, but the message was still seen. It was confirmed that the programming system is not plugged into the wall. When the wand was switched with a known working handheld and serial cable, the system worked. When the physician's handheld and serial cable was used with a known working wand, it would not communicate. The issue was therefore isolated to the handheld and serial cable. No patients were affected by the issue. Review of the device manufacturing records for the handheld confirmed the handheld met all final testing specifications prior to distribution.
 
Event Description
It was reported that the physician's handheld has had problems in the past and is now not able to hold a charge. A new programming tablet was requested. The physician's handheld and handheld serial cable were returned for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
An analysis was completed on the returned handheld and no anomalies associated with the serial cable were noted during testing using the ac adapter or the main battery with a full charge. The serial cable performed according to functional specifications. No anomalies associated with the main battery were noted during testing using the ac adapter or the main battery with a full charge. During the analysis, it was identified that the handheld was unable to advance past the screen alignment utility. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the flex cable was pressed onto the display, the resistance values dropped to. 412k ohms and the touchscreen performed with no further anomalies. No further anomalies associated with the handheld performance were identified during the analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3454976
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dennis100
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« Reply #223 on: June 15, 2018, 12:40:17 AM »

Model Number 250
Event Date 01/01/2010
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 a physician's handheld computer did not always respond to taps on the screen. The physician had tried aligning the screen several times but the issue prevails. The physician requested a new programming system. The reported programming system was returned to the manufacturer and is currently undergoing product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1706610
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dennis100
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« Reply #224 on: July 23, 2018, 03:47:25 AM »

Model Number MODEL 250
Event Date 07/21/2016
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2016 by a medical professional that their programmer serial cable was frayed and was causing issues establishing communication. The handheld, serial cable, and power cable were received for analysis on 08/01/2016. Analysis was completed on the returned handheld 08/18/2016. A visual analysis of the serial cable was able to identify that the outer insulation was damaged at the cable strain relief. Functional testing of the cable was able to verify that the damage was cosmetic and had no functional impact on the serial cable performance. Also 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 leads associated with the handheld sync connector. Because of the damage, the handheld was unable to receive power from the ac adapter. The leads were soldered to the pcb during analysis. It was also identified that the handheld was received with the lock button in the locked position and the handheld buttons and touchscreen were unresponsive. Once the lock button was moved to the unlocked position no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5890633
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« Reply #225 on: October 12, 2018, 04:01:13 PM »

Model Number 201
Event Date 06/20/2012
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by a company representative that a physician's handheld computer and programming wand would not work to interrogate a vns patient. The area representative indicated the programming wand was badly coiled and could not rule out one of the two devices. At the moment, the reported handheld and wand returned to the manufacturer and remain under analysis.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the wand. The failure to program event was confirmed in product analysis. The serial data cable, which produced communication errors, had intermittent conductors at the handle location and the returned battery was depleted. After a known good bench serial data cable and a known good bench battery were substituted, all communications errors cleared. Product analysis on the handheld was completed on (b)(6) 2012. During the analysis it was identified that the touchscreen display was unresponsive (reported on mfg report # 1644487-2012-01996). The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. As the handheld is not manufactured by cyberonics, the cause for the anomaly is unknown. Product analysis on the flashcard was completed on (b)(6) 2012, as well. 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=2652892
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« Reply #226 on: October 13, 2018, 04:22:29 AM »

Model Number MODEL 250
Event Date 06/04/2012
Event Type  Malfunction   
Event Description
Additional information was received that the handheld was dropped by hospital personnel. The handheld at this time is not being returned for analysis.
 
Manufacturer Narrative
 
Event Description
It was reported by a company representative that a handheld computer screen was cracked due to unknown reason. The handheld computer can still be switched on and off and is in working order, but the area representative indicated that since it is a touchscreen, they can no longer use it. At the moment, attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2648011
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« Reply #227 on: October 22, 2018, 01:49:11 PM »

Model Number MODEL 250
Event Date 08/08/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012, it was reported that a handheld device screen freezes at times and that the screen alignment is totally out. A soft reset was performed, followed by a hard reset. This was done three times; however, the error could not be rectified. The device could not return to functionality and could not perform an interrogation at all. Additional information was received that a hard reset was performed only once. A blue screen was seen indicating clear all data in the memory. During the screen alignment process, attempts to align according to the prompts were made for five to ten minutes before moving to the next prompt. The event occurred during implant. With the existing device, and wand, the physician was unable to perform an interrogation and could not get it to the mode intended. The physician used a new handheld device and the existing wand and was able to interrogate and perform system diagnostics. The physician attempted to use the handheld device on another patient later in the day but encountered the same problem. Utilizing another handheld device, again, resolved the issue. References were made to a video detailing the event; however, the video has not been accessible. The handheld device and software flashcard were received on (b)(4) 2012 and are currently undergoing product analysis.
 
Event Description
Product analysis was approved on (b)(6) 2012. 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 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2726459
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« Reply #228 on: October 25, 2018, 01:21:20 AM »

Model Number 250
Event Date 08/06/2012
Event Type  Malfunction   
Event Description
The handheld was returned to our europe office prior to shipment to houston. Upon review, the touchscreen seems not to respond properly to touches with the stylus, as sometimes the commands can be activated by touching the screen insistently or strongly, but most of the occasions the screen just does not respond. One interrogation of a "not for human use" generator was successfully completed by attempting many times to start it, repeatedly touching the "interrogate device" button. This appears to be a mechanical problem - screen responsiveness issue. The serial cable and the charger were not included. The handheld and software have been received for analysis and completion is pending.
 
Manufacturer Narrative

Event Description
Product analysis of the serial cable was approved on (b)(6) 2013. An analysis was performed on the returned serial cable and the reported "faulty serial cable" allegation was not verified. No anomalies associated with the serial cable were noted during testing. The serial cable performed according to functional specifications.
 
Manufacturer Narrative
Name of device, corrected data: previously submitted mdr indicated this was the programming software. Additional information was received indicating that the suspect medical device is the programming computer. Device available for evaluation, corrected data: a previously submitted mdr indicated that the suspected medical device was returned for evaluation. Additional information was received indicating that the suspect medical device was different from that initially reported and has not been returned. Device evaluated by mfr, corrected data: the suspected medical device has not been returned for evaluation. This report is being submitted to correct this information.
 
Event Description
Product analysis was completed 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. During the analysis it was identified that the software would pause following an interrogation. This is expected behavior for the software considering the database size. The flashcard and software performed according to functional specifications. The handheld was returned for the following alleged reason: "mechanical problem, screen responsive issue". An analysis was performed on the handheld and the reported allegation was not verified. No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. On (b)(6) 2012, it was reported that event was resolved following replacement of the wand to handheld connector cable. Attempts for product return have been unsuccessful.
 
Event Description
The handheld serial cable was received for analysis (b)(6) 2013. Analysis is pending.
 
Event Description
A physician from spain reported that his handheld computer stopped working. He performed a reset five times and it still did not respond. The event did resolve with troubleshooting but is a reoccurring event. The handheld is being attained for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2725298
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dennis100
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« Reply #229 on: October 27, 2018, 12:32:11 AM »

Model Number MODEL 250
Event Date 10/09/2012
Event Type  Malfunction   
Event Description
A nurse reported that she was using her dell x50 handheld computer, and a screen came up asking her to select a language. She indicated that it was on english and that she was pressing "ok" but nothing would happen. The nurse performed a hard reset and indicated that everything was then working fine. She stated that the handheld had been acting strangely recently because she had to tap the screen multiple times for the handheld to respond. However, she confirmed that it always did respond and also noted that it only occurred occasionally. The issue always resolves by just pressing the button a couple of times. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2796608
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« Reply #230 on: October 27, 2018, 12:32:52 AM »

Model Number MODEL 250
Event Date 09/13/2012
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the physician's vns programming handheld computer was experiencing screen freezes, typically at the interrogation successful screen. A hard reset usually resolves the issue. The physician indicated that he was frustrated having to perform troubleshooting during surgery and requested a replacement programming system. The faulty handheld computer programming system was returned and underwent analysis. The screen freezing issue was confirmed as reported. No adverse events have been reported as a result of the screen freezing issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2787243
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dennis100
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« Reply #231 on: November 03, 2018, 12:13:16 AM »

Model Number MODEL 250
Event Date 11/29/2012
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.
 
Manufacturer Narrative
Supplemental mfr. Report #4 inadvertently listed the wrong date. The date should be (b)(4) 2013.
 
Event Description
An update was received on the status of the handheld. It was stated that the handheld computer was not working on (b)(6) 2013. A reset was performed, but it was stated that "touch not working". Based on additional updates, then handheld was not working on (b)(6) 2013 either, for the same reason. Attempts will be made for additional information. No further information has been provided.
 
Manufacturer Narrative

Event Description
Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.
 
Event Description
Reporter indicated that the handheld device was not working, indicating that it would "hang". Reporter noted that they tried to shut it down, but the problem still exists. Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported that the touch screen was not working. It was noted that after a few days it automatically responded and the touch was working, but that when the handheld is switched on it went to the touch sensitivity page and stops there. It was reported that a hard reset would not correct the problem. 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 on (b)(4) 2013. 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. Analysis of the handheld was completed on (b)(4) 2013. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2883047
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« Reply #232 on: December 02, 2018, 01:23:29 AM »

Model Number MODEL 250
Event Date 06/26/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to any serious injury or death.

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

Event Description
On (b)(6) 2013 information was received from the reporter that the physician¿s handheld computer cannot align its screen. Several hard resets were performed on the computer, with no changes resulting. The screen was wiped very cleanly with a dry towel/cloth, but the screen was still unable to align. The handheld computer and its flashcard have been received for product analysis. Additional information is pending completion of manufacturer product analysis.

Event Description
Analysis of the computer and flashcard was completed. During the analysis it was identified that the handheld was unable to advance past the screen alignment utility. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. There were no performance or any other type of adverse conditions found with the handheld computer. The flashcard software performed according to functional specifications. No anomalies associated with flashcard software or databases were identified during the flashcard analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3233793
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« Reply #233 on: December 06, 2018, 01:05:42 AM »

Model Number MODEL 250
Event Date 07/10/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
An analysis was performed on the returned handheld. During the analysis it was identified that the handheld could not complete the screen alignment utility during the initial setup process. The cause for the anomaly is associated with debris that was trapped under the case. Once the display was cleaned, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. 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. Review of the device manufacturing records indicated that the device passed all final tests prior to distribution. No other information has been provided.

Event Description
It was reported that the vns treating physician¿s vns handheld was not working. The company representative performed troubleshooting, and once it resets, it says to tap the screen but will not respond. After trying to tap the screen as prompted, the screen did not respond. The representative tried performing a hard reset multiple times but was unable to get past that screen. A replacement handheld device was provided to the physician and faulty programming system was returned to the manufacturer for analysis. However, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3262740
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« Reply #234 on: December 13, 2018, 03:48:26 AM »

Model Number MODEL 250
Event Date 08/14/2013
Event Type  Malfunction   
Event Description
It was reported that the physician handheld was stuck on the "welcome to vns" screen. A hard reset was performed and the align screen process was attempted several times; however, the screen would not leave the allign screen. A new programming tablet was provided to the physician. The handheld is expected to be returned, but has not been received to date.

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

Manufacturer Narrative

Event Description
The handheld was returned for analysis on 09/26/2013. Analysis of the handheld was completed on 10/21/2013. An analysis was performed on the returned handheld and the reported allegation was verified. During the analysis it was identified that the handheld was unable to advance past the screen alignment utility. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. Analysis of the flashcard was completed on 10/21/2013. 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=3342994
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« Reply #235 on: December 15, 2018, 01:22:24 AM »

Model Number MODEL 250
Event Date 09/24/2013
Event Type  Malfunction   
Manufacturer Narrative
Event Description
On (b)(6) 2013, the physician reported that they were testing the handheld and found that it stays frozen even after hard resetting the device. The hard reset was tried several times and the handheld was checked and confirmed to be unlocked. The screen was wiped down well, but it was not responding to taps. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3425914
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« Reply #236 on: December 15, 2018, 01:23:15 AM »

Model Number MODEL 250
Event Date 09/25/2013
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 physician's handheld device would not move past the set up screen after a hard screen. It was stated that the handheld was at the interrogation screen with the patient's parameters on the screen. A hard reset was performed to try and get past this screen, and the handheld went back to the first screen that directs you to the tap screen. From here, the manufacturer's representative could not move forward while troubleshooting. The hhd was received with a serial cable, v8. 1 flashcard, and with the main battery, but without an ac adapter. Visual inspection identified no anomalies. The handheld device was powered using a known good ac power supply with no anomalies. Attempted to advance past the welcome screen but was unable. The touchscreen was unresponsive. The returned display was removed. Continuity testing of the returned display identified an anomaly associated with the trace that is routed to pin 1 of the touch screen flex cable. Resistance readings associated with the circuit was higher than expected; read approximately 2k ohms ¿ nominal is approximately. 418k ohms. Pressed on the flex cable where it attaches to the touch screen. It was identified that the resistance reading was still significantly higher than expected. A known good display was installed in the handheld in order to continue testing. The handheld device was powered using a known good ac power supply with no anomalies. The returned flashcard was inserted and the vns v8. 1 software was installed with no observed anomalies. Interrogation and diagnostic tests were performed successfully with no observed anomalies using the v8. 1 software and a 103 generator. The handheld computer was powered-on continuously using only the main battery for more than an hour. For five successful times the following occurred: the generator was interrogated, then the output and magnet currents increased from 0ma to 0. 5ma, then interrogated to verify the new settings, then a generator diagnostic test was performed during which the generator values were changed back to output currents of 0ma, and then the battery was interrogated to verify new settings. The main battery had a remaining charge of 70% at the conclusion of testing. During the analysis it was identified that the handheld was unable to advance past the welcome screen. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3427501
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« Reply #237 on: December 18, 2018, 12:01:11 PM »

Model Number MODEL 250
Event Date 09/11/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician's handheld would not go past the initial screen after a hard reset. It was reported that the screen indicates to tap screen to continue, but the handheld was frozen. Troubleshooting was performed by checking to ensure the lock button was not engaged and by performing a hard reset. The physician was provided a new programming tablet and the handheld was returned for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3403563
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« Reply #238 on: December 19, 2018, 12:19:00 PM »

Model Number MODEL 250
Event Date 10/09/2013
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).

Event Description
The handheld and flashcard was received for analysis. Analysis of the handheld was completed on (b)(4) 2014. The serial cable was not returned for analysis. No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. 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 manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

Event Description
It was reported that the physician's handheld was not always responding to tapping on the screen when trying to interrogate. It was reported that this has been occurring for approximately two weeks. The physician was given a new programming tablet. The handheld is expected to be returned for analysis, but has not been received to date.

Event Description
The physician's office reported no issues with the new replacement tablet and existing wand. Good faith attempts for product return of the handheld device have been unsuccessful to date. The handheld device has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3479375
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« Reply #239 on: December 22, 2018, 09:26:08 AM »

Model Number MODEL 250
Event Date 11/25/2013
Event Type  Malfunction  
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.

Event Description
The physician reported that the handheld was unresponsive. The handheld was reset; hwoever, touch screen did not respond to any of the stylus touches and would not align. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3537143
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