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dennis100
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« Reply #240 on: December 23, 2018, 10:31:26 AM »

Model Number MODEL 250
Event Date 11/21/2013
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
It was reported that the physician's handheld is unresponsive to the stylus. It was reported that troubleshooting found that the handheld only responds to the stylus every 3rd tap. The physician was sent a new programming tablet and the handheld was received for analysis. Analysis is underway, but has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528587
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dennis100
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« Reply #241 on: December 26, 2018, 12:01:52 PM »

Model Number MODEL 250
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013, the physician reported that the handheld was not responding really well to taps. A hard reset was performed, and then the screen became stuck on the screen that gives the choices "set time" or "continue". It was noted that none of these choices were responding to his taps. When he did the reset, the screen just went out and came to this screen. During the reboot, the screens asking to copy and paste the appointment and the alignment screen did not appear. The manufacturer's representative got to the alignment screen and tapped on the crosshair that moved around on the screen. He said he tapped more than 10 times and didn't progress. Confirmed that he was using a stylus and tapping in the middle of the crosshairs. It would not progress even after so many taps. The crosshair just went around and around the screen. Another hard reset was performed with the same results. Verified that the handheld was plugged in all the time, on a desk in a dry, cool area. There are no signs of damage to the handheld or screen and it is not dirty. The physician did not know when the issue first started. The handheld and flashcard were returned to the manufacturer and product analysis was performed. The back-up battery was removed. The back-up battery voltage with no load measured 486mv (nominal (b)(4)). This is an indication that the back-up battery has been depleted. The handheld device was powered using the returned ac power supply adapter with no observed anomalies. An attempt was made to perform the initial setup process, but it was unable to advance past the screen alignment utility. The crosshair would move in response to the screen taps, but the handheld software would not advance to the next setup utility. The handheld case was opened and it was identified that there was debris trapped between the display and handheld case. The debris was removed and the display cleaned. The handheld device was powered using the returned ac power supply adapter with no observed anomalies. The initial setup process was performed with no observed anomalies. The back-up battery indicator read 0% which is expected because the back-up battery will discharge if the unit is not supported by an external power source. 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¿s main battery was fully recharged successfully using the power supply adapter. The power button light on the hhd was amber and then later turned green giving the indication that the main battery was fully charged. Interrogation and diagnostic tests were performed successfully with no observed anomalies using a 102 generator. The handheld was powered-on continuously using only the main battery for more than an hour. 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 0 ma, and then the battery was interrogated to verify new settings. The main battery had a remaining charge of 75% at the conclusion of testing. An analysis was performed on the returned handheld and a cause for the reported allegation was verified. 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. The flashcard was returned with the allegation of no malfunction suspected/identified. No anomalies were identified via external inspection. V8. 1 software was installed and verified on the main screen with no anomalies. Interrogation and diagnostic tests were performed with no anomalies on a 103 generator. No anomalies were observed when diagnostic, parameter, and magnet history databases were viewed. For five successful times the following occurred: the generator was interrogated, then the output and magnet currents increased from 0ma to 0. 5 ma, 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 0 ma, and then the battery was interrogated to verify new settings. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3519988
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dennis100
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« Reply #242 on: December 30, 2018, 06:09:33 AM »

Model Number MODEL 250
Event Date 12/19/2013
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld was at the align screen and keeps going "around and around". Troubleshooting was performed by a manufacturer employee. The battery was removed and reinserted, a hard reset was performed; however, the screen still continues to go "around and around". The edges of the screen were cleaned with a card and this did not resolve the issue. A new programming tablet was sent 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 death or serious injury.
 
Event Description
The handheld device was returned to the manufacturer for analysis. Analysis of the returned handheld found that 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.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3577154
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dennis100
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« Reply #243 on: January 11, 2019, 02:26:32 AM »

Model Number MODEL 250
Event Date 01/23/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the suspect medical device passed all functional tests prior to distribution.
 
Manufacturer Narrative
Corrected data: this information on follow-up mfr. Report #2 was inadvertently reported incorrectly. The date should have been reported as (b)(6) 2014 rather than 05/13/2014.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the handheld was frozen and a hard reset was performed. It was reported that the handheld would not progress from the screen alignment. It was reported that the alignment is done and the screen detects the taps, but the software requests to have the alignment performed again. A new programming computer was requested and the handheld was returned for analysis. The handheld analysis was completed on 07/07/2014. During the analysis it was identified that the handheld was unable to advance past the screen alignment utility due to resistance values being higher than expected in the touch screen circuitry. No further anomalies associated with the handheld performance were identified during the analysis. Analysis of the flashcard was completed on 07/07/2014. 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 physician was having issues with her programming system. Follow-up revealed that the physician¿s handheld device had a screen that would sometimes be unresponsive to the stylus. A new stylus was used, a hard reset was performed, the handheld was recalibrated, but this was unsuccessful in resolving the screen issues. Attempts for product return have been unsuccessful.
 
Event Description
Additional information was received stating that the handheld device was functioning properly with no issues; therefore, the product will not be returned. It was reported that a glitch may have occurred that caused the initial issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3772047
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dennis100
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« Reply #244 on: January 17, 2019, 01:41:39 AM »

Model Number MODEL 250
Event Date 06/02/2014
Event Type  Malfunction   
Manufacturer Narrative
Serial #, lot #, other, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.
 
Manufacturer Narrative

Event Description
Product information was obtained. The handheld device has been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution. Device failure occured, but did not cause or contribute to death or serious injury.
 
Event Description
Review of the device manufacturing records that the handheld device passed all functional tests prior to distribution. Product analysis on the returned handheld device was completed. 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 during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
It was reported that the screen and buttons on the handheld device were not responding. The handheld showed the alignment screen when powered on but was subsequently unresponsive. The edges of the screen were cleaned and a hard reset was performed, but the issue did not resolve. The handheld device has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3902233
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dennis100
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« Reply #245 on: January 17, 2019, 01:42:40 AM »

Model Number MODEL 250
Event Date 06/11/2014
Event Type  Malfunction   
Event Description
Additional information was received clarifying that the handheld device had a frozen screen and was not responding to the user. The handheld device is expected to be returned to the manufacturer for analysis but has not been returned to date.
 
Manufacturer Narrative
Lot #, corrected data: previously submitted mdr incorrectly reported this information.
 
Event Description
It was reported that the physician's handheld does not respond to any command and has self behave. It is unknown if troubleshooting was performed. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the hospital staff was well trained in proper usage of the handheld. The handheld device was programmed off and intentionally returned with the lock button engaged.
 
Manufacturer Narrative

Event Description
The handheld and flashcard were received for analysis. Analysis of the handheld was completed on (b)(4) 2014. During the analysis it was identified that the handheld was received with the lock button in the locked position. Since the lock button was locked, the handheld buttons and touchscreen were unresponsive. Once the lock button was moved to the unlocked position no 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) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3892490
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dennis100
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« Reply #246 on: January 20, 2019, 01:34:15 AM »

Model Number MODEL 250
Event Date 05/29/2014
Event Type  Malfunction   
Event Description
It was reported that the neurologist¿s handheld device was working slowly. The handheld device was returned for analysis. Analysis 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. 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3955120
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dennis100
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« Reply #247 on: January 20, 2019, 01:35:12 AM »

Model Number MODEL 250
Event Date 07/08/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury. Serial #, lot #, other, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.
 
Manufacturer Narrative

Event Description
It was reported that the neurologist was having issues with her handheld device. The handheld screen reportedly did not respond to the handheld stylus. It was confirmed that the screen lock switch was not engaged and that the battery latch was closed. A hard reset was performed but the issue did not resolve. A replacement device was provided but the unresponsive handheld has not been returned to date.
 
Event Description
The handheld device and software flashcard were returned to the manufacturer for analysis. 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 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=3970711
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dennis100
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« Reply #248 on: January 21, 2019, 11:04:44 AM »

Model Number MODEL 250
Event Date 06/24/2014
Event Type  Malfunction   
Event Description
It was reported that the neurologist¿s handheld screen was unresponsive. Hard resets were performed but the issue did not resolve. The handheld device has 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.
 
Manufacturer Narrative

Event Description
On (b)(6) 2014 the handheld and flashcard were returned for product analysis. An analysis was performed on the returned handheld and the unresponsive screen event was confirmed. 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. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3942164
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dennis100
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« Reply #249 on: January 21, 2019, 11:05:38 AM »

Model Number MODEL 250
Event Date 06/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician¿s handheld was freezing during interrogation. A company representative performed troubleshooting and hard resets did not resolve the freezing screen. A new programming computer was provided to the physician. The handheld was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the handheld was completed on 08/06/2014. An analysis was performed on the returned handheld and 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 08/06/2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3950092
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dennis100
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« Reply #250 on: January 21, 2019, 11:06:26 AM »

Model Number MODEL 250
Event Date 06/23/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld was not functioning properly. Troubleshooting was performed. A hard reset was performed and when the handheld got to the alignment screen it was stuck in an infinite loop. Another hard reset was performed but the user was again unable to move past the alignment screen. A new programming computer was provided to the physician and the handheld was returned for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis on the returned handheld device was completed. 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 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 death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3942161
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dennis100
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« Reply #251 on: January 24, 2019, 04:14:56 AM »

Model Number MODEL 250
Event Date 07/31/2014
Event Type  Malfunction   
Event Description
It was reported that the neurologist was unable to pass the alignment screen on her handheld device. Multiple hard resets were performed, the screen was cleaned, and the lock button was confirmed to be not engaged. However, the issue did not resolve. The handheld device was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
Analysis of the returned handheld device and software flashcard was completed. During 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 during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
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=4037865
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dennis100
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« Reply #252 on: January 24, 2019, 04:15:41 AM »

Model Number MODEL 250
Event Date 07/31/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld was unable to interrogate a patient's generator. The patient's generator was able to be interrogated with another programming system. Troubleshooting was performed and the handheld was unable to establish communication with a demo generator. The programming wand was switched out with another wand and communication with the demo generator continued to fail. A hard reset was performed and still was unable to communicate with the demo generator. The physician requested a new programming computer. The handheld was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.
 
Event Description
Analysis of the returned handheld device and software flashcard was completed. It was verified 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. 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4044088
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dennis100
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« Reply #253 on: January 25, 2019, 08:30:26 AM »

Model Number 250
Event Date 07/23/2014
Event Type  Malfunction   
Event Description
Analysis of the handheld was completed on 08/25/2014. 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. Analysis of the flashcard was completed on 08/25/2014. 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 confirmed that the handheld passed all functional tests prior to distribution. Electronic submission of this report was not possible due to a problem with the manufacturer's software used for emdr submissions.
 
Event Description
It was reported that the neurologist was having issues getting past the screen alignment screen on his handheld device. Multiple resets were performed on the handheld and the neurologist was careful to press the inside of each crosshair; however, the issue did not resolve. The handheld device was 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=4092662
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dennis100
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« Reply #254 on: January 25, 2019, 08:31:14 AM »

Model Number MODEL 250
Event Date 01/01/2014
Event Type  Malfunction   
Event Description
It was reported that the neurologist¿s handheld device was stuck on the blue screen. Multiple hard resets were performed and the battery and flashcard were reseated; however, the issue did not resolve. A hard reset eventually allowed the neurologist to move past the blue screen to the screen alignment screen, but the handheld device would not respond to the stylus in order to complete the screen alignment. The neurologist confirmed that the lock button was not engaged. The handheld device was returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned handheld device and software flashcard was completed. 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 software anomalies associated with the handheld were noted during testing using the 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
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=4012164
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« Reply #255 on: January 26, 2019, 03:08:12 AM »

Model Number MODEL 250
Event Date 07/18/2014
Event Type  Malfunction   
Event Description
It was reported that neurologist was having issues with the handheld device. Hard and soft resets were performed but the issues did not resolve. The handheld device was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative

Event Description
Analysis of the returned handheld device and software flashcard was completed. 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. An intermittent power connection associated with the serial cable was also identified. The cause for the anomaly is associated with a bent serial cable plug leaf spring that prevented electrical contact with the ac adapter barrel connector. The cause for the bent spring is unknown, but is most likely associated with mishandling of the device. 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=4003851
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« Reply #256 on: January 26, 2019, 03:09:12 AM »

Model Number MODEL 250
Event Date 07/23/2014
Event Type  Malfunction   
Event Description
Analysis of the returned handheld device and software flashcard was completed. It was verified 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. 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative

Event Description
The handheld was received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
It was reported that the surgeon was having issues advancing through the alignment screen. The lock button was not engaged, hard resets were performed, and the battery was reseated; however, the issues did not resolve. The stylus was reportedly used precisely onto the crosshairs on the alignment screen and the edges of screen were clean. The programming wand was connected to a tablet device and confirmed to be functioning properly. The handheld device has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4018891
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« Reply #257 on: January 26, 2019, 03:09:58 AM »

Model Number MODEL 250
Event Date 07/16/2014
Event Type  Malfunction   
Event Description
On (b)(6) 2014 product analysis was completed on the handheld and flashcard. The flashcard and software performed according to functional specifications. An analysis was performed on the returned handheld and no software anomalies were identified during the analysis. 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.
 
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=3997927
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« Reply #258 on: January 27, 2019, 05:30:17 AM »

Model Number MODEL 250
Event Date 09/02/2014
Event Type  Malfunction   
Event Description
The handheld device and software flashcard were returned to the manufacturer for 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 during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
It was reported that the physician¿s handheld was not working properly that day. The hhd would get stuck in the screen alignment despite tapping on the cross symbol correctly. A hard reset was performed multiple times, but did not resolve the issue. It was reported that another programming system was available so no patient care was affected. A new programming tablet was provided to the physician. The handheld is expected to be returned for analysis, but has not been received to date.
 
Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4125213
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« Reply #259 on: January 28, 2019, 05:25:51 AM »

Model Number MODEL 250
Event Date 08/26/2014
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
It was reported that the physician's handheld was stuck in the screen alignment loop. Troubleshooting was performed which did not resolve the issue. The physician 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 device and software flashcard were returned to the manufacturer for analysis. The cause for the allegation is associated with resistance values being higher than expected in the touch screen circuitry. 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4112993
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dennis100
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« Reply #260 on: January 29, 2019, 06:43:02 AM »

Model Number MODEL 250
Event Date 08/20/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician's handheld screen will not respond to touch. A hard reset was performed which did not resolve the event. The physician was provided a new programming tablet. 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=4097149
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dennis100
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« Reply #261 on: January 29, 2019, 06:44:13 AM »

Model Number MODEL 250
Event Date 08/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
Analysis of the returned handheld device and software flashcard was completed. 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. No anomalies associated with the main battery 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.
 
Manufacturer Narrative

Event Description
It was reported that the nurse practitioner's handheld was not holding a charge, nor would the screen respond after a hard reset. Troubleshooting was performed by confirming that the hard reset was performed correctly and the screen was cleaned, the battery was removed and reinserted and the screen lock was confirmed to not be engaged. Troubleshooting was unable to resolve the issues. The nurse practitioner was provided a new programming tablet and the handheld was received 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=4102901
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dennis100
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« Reply #262 on: January 30, 2019, 08:37:55 AM »

Model Number MODEL 250
Event Date 08/07/2014
Event Type  Malfunction   
Event Description
Analysis of the handheld was completed on (b)(4) 2014. During the analysis it was verified 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. No further anomalies associated with the handheld performance were identified during the analysis. 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
The handheld and flashcard were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
It was reported that the neurologist handheld device was not responding to the stylus. A hard reset was performed, but the handheld device was unable to pass the alignment screen despite precisely in the crosshairs. It was noted that the handheld sometimes responded initially but would eventually be unresponsive. The handheld screen and underneath the edges of the screen had been cleaned. The handheld device has not been returned to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4060981
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dennis100
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« Reply #263 on: January 31, 2019, 01:23:57 AM »

Model Number MODEL 250
Event Date 09/05/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis of the returned handheld device and software flashcard was completed. 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 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 death or serious injury.
 
Event Description
It was reported that the handheld is not functioning properly. It was reported that the handheld screen frequently freezes. It was reported that the battery screen shows an exclamation mark. Troubleshooting was performed and a test interrogation was performed. The screen froze and a hard reset was performed. The screen froze again. The physician has another handheld and tablet and does not need a replacement. The handheld and flashcard were received 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=4209501
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dennis100
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« Reply #264 on: February 01, 2019, 11:38:28 AM »

Model Number MODEL 250
Event Date 09/22/2014
Event Type  Malfunction   
Event Description
The handheld and related software were received by the manufacturer for analysis. However, analysis has not been completed to date. It was noted that the handheld was received with a cracked screen, but the company representative reported that it was not cracked prior to shipment. Therefore, it was damaged in the shipping to the manufacturer.
 
Manufacturer Narrative
Manufacturer device history records were reviewed. Review of the handheld device history record confirmed all quality specifications were passed prior to distribution.
 
Event Description
An analysis was performed on the returned handheld and software, and the reported allegation could not be verified. The handheld display and touchscreen were damaged during shipping and were no longer functional. A visual analysis of the handheld was able to verify that the display was cracked. The cause for the cracked screen is associated with mishandling of the device as previously reported. 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. No anomalies associated with flashcard software or databases were identified during the flashcard analysis.
 
Manufacturer Narrative

Event Description
It was reported that the handheld dell x50 was unresponsive to touch. A hard reset was attempted, but when the align screen prompt was received, the screen was unresponsive to touch. A replacement product was provided. The product has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4180848
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dennis100
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« Reply #265 on: February 10, 2019, 03:07:02 AM »

Model Number MODEL 250
Event Date 12/17/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the physician¿s handheld was continually cycling through the alignment screen and would not continue to the next step. Hard resets were attempted but did not resolve the issue. A replacement tablet was provided. The suspect handheld has not been received to date for analysis.
 
Event Description
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. 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.
 
Manufacturer Narrative

Event Description
The handheld device was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4397143
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« Reply #266 on: February 13, 2019, 01:45:58 AM »

Model Number MODEL 250
Event Date 01/20/2015
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 was broken and had not worked in some time. The handheld has been kept in the office in the box unused. There were other programming systems available so no patient care was interrupted. The handheld and tablet were received for analysis. Analysis of the handheld was completed on (b)(4) 2015. 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. No further anomalies associated with the handheld performance were identified during the analysis. 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=4521867
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dennis100
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« Reply #267 on: February 21, 2019, 11:37:39 AM »

Model Number MODEL 250
Event Date 03/22/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the physician's handheld was freezing at the alignment screen. It was reported that tapping the cross at the center of the screen does not work. It was reported that this was attempted approximately 15 times. The physician was provided a new programming computer. The handheld is expected to be returned for analysis, but has not been received to date.
 
Event Description
The handheld computer and the software flashcard were received by the manufacturer on 04/17/2015. Analysis of the handheld confirmed that the device 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. No further anomalies associated with the handheld performance were identified. Analysis of the software flashcard found no anomalies. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4700245
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dennis100
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« Reply #268 on: March 04, 2019, 07:38:51 AM »

Model Number MODEL 250
Device Problem Failure to Interrogate
Event Date 06/23/2015
Event Type  Malfunction   
Event Description
Analysis was completed on the handheld and software, and the reported allegation was confirmed. 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. The flashcard and software performed according to functional specifications.
 
Event Description
The nurse reported that she was unable to advance to the interrogation screen from the main menu. She was unable to advance past the first screen on her handheld. During the report, the screen lock was switched to the lock position and then back to the unlock position. A hard reset was attempted, and the edges of the screen were cleaned. Another hard reset was performed. It was confirmed that the stylus was being used, but was still unable to advance past the screen. The handheld and related software were received by 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=4913626
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dennis100
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« Reply #269 on: March 05, 2019, 05:21:46 AM »

Model Number MODEL 250
Device Problems Keypad; Device Inoperable
Event Date 07/29/2015
Event Type  Malfunction   
Event Description
The suspect device was received by the manufacturer. Analysis of the device is underway, but it has not been completed to date.
 
Event Description
An analysis was performed on the returned handheld and 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. An analysis was performed on the returned flashcard. During the analysis it was identified that the vns files had been deleted from the flashcard and were stored in the. Trashes folder. Evidence suggests the files had to have existed on the flashcard at one time. Additionally, it was identified that the flashcard contained 2 different sets of patient data. The cause for the multiple database anomaly is associated with the flashcard being using in multiple handheld devices. No other anomalies were identified.
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong suspect device for the event.
 
Manufacturer Narrative

Event Description
It was reported that the touchscreen of the handheld computer would not respond to taps. The handheld computer was reset a number of times. It was verified that the lock button was not activated. The handheld computer's battery was removed and put back in. The reported event did not resolve. The suspect handheld computer has not been returned to the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5017242
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