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Author Topic: Handheld Computer/Programming Wand  (Read 218589 times)
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dennis100
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« Reply #30 on: January 31, 2017, 01:32:06 AM »

Model Number 201
Event Date 08/06/2008
Event Type Malfunction
Event Description
Reporter indicated a vns programming handheld, produced an error message, "unable to establish communication", when interrogating a patient's device. Troubleshooting resolved the issue. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1156420
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dennis100
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« Reply #31 on: January 31, 2017, 01:32:52 AM »

Model Number 201
Event Date 07/30/2008
Event Type Malfunction
Event Description
It was reported that a programming system was producing communication errors when trying to communicate with a demo generator. Troubleshooting did not resolve the issue. The programming wand was returned to the manufacturer for analysis. Product analysis revealed that the serial adapter cable had an intermittent conductor which was producing the communication errors.

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=1132729
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dennis100
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« Reply #32 on: January 31, 2017, 01:33:39 AM »

Model Number 201
Event Date 07/09/2008
Event Type Malfunction
Event Description
It was reported that a programming wand was not working. Troubleshooting did not resolve the issue. The programming wand was returned to the manufacturer for analysis. It was identified that the serial data cable had an intermittent conductor which produced communication errors. It was also visualized that the strain-relief grommet was dislodged rendering the strain-relief function ineffective. It was confirmed that the dislodged strain-relief grommet did not compromise the integrity of the serial data cable connections.

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=1085039
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dennis100
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« Reply #33 on: January 31, 2017, 01:34:22 AM »

Model Number 201
Event Date 07/02/2008
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated the cord on her vns programming wand is frayed and is causing problems. Good faith attempts to obtain additional information have been unsuccessful to date. The wand has been returned to the manufacturer and is pending product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1097743
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dennis100
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« Reply #34 on: January 31, 2017, 01:35:04 AM »

Model Number 201
Event Date 07/24/2008
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

Event Description
It was reported to manufacturer that the site was experiencing communication difficulties with the programming wand. Troubleshooting was performed which included resetting the hand held, checking the cable connections and replacing the 9v battery, none of which resolved the communication problems. The non-working programming wand was returned to manufacturer for analysis. Analysis revealed that the serial data cable which produced communication errors, had an open conductor and the wand battery was depleted. After the serial data cable and the battery was substituted, the device performed as intended.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1134876
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dennis100
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« Reply #35 on: January 31, 2017, 01:35:51 AM »

Model Number MODEL 250
Event Date 07/01/2008
Event Type Malfunction
Event Description
It was reported that the serial adapter cable and the wand were malfunctioning. Reporter has been facing communication problems when using the wand with other handhelds and his handheld with other wands. Troubleshooting was performed and the system was returned for product analysis. Product analysis on the wand revealed that the serial adapter cable is the problem component due to an intermittent conductor. A known good bench serial data cable was substituted and all communication errors cleared.

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=1133586
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dennis100
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« Reply #36 on: January 31, 2017, 01:36:59 AM »

Model Number 201
Event Date 01/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that a physician was having screen freezing with their handheld. A new handheld was sent to the physician. They continued to have the same problems as before. Further investigation revealed that there was no screen freezing issue, it was a communication problem with their programming wand. A different wand was used and it interrogated successfully. Product return and analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1119848
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dennis100
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« Reply #37 on: January 31, 2017, 01:38:02 AM »

Model Number 201
Event Date 07/23/2008
Event Type Malfunction
Event Description
Reporter indicated a vns wand failed to program pts. The vns wand was returned for product analysis. Analysis revealed that the wand serial data cable, which produced communication errors, had an open conductor. A known good bench serial data cable was submitted and all communications errors cleared.

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=1111875
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dennis100
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« Reply #38 on: January 31, 2017, 01:38:50 AM »

Model Number 201
Event Date 07/10/2008
Event Type Malfunction
Event Description
Initial reporter indicated that their programming wand had malfunctioned. It would not interrogate pt's. The batteries were changed and the data received light never appeared. A manufacturing consultant utilized their own programming wand which resolved the situation as far as interrogating pt's. Manufacturer is pending receipt of the programming wand for analysis.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1098527
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dennis100
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« Reply #39 on: January 31, 2017, 01:40:08 AM »

Model Number 201
Event Date 07/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that a programming wand was not "working good at all times. " the wand was tested, and could perform an interrogation, and programming on a demo generator, without any problems. The wand was returned to the mfr. Product analysis revealed that the serial data cable, which produced the communication errors, had intermittent conductors. No other anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1156416
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dennis100
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« Reply #40 on: January 31, 2017, 01:40:56 AM »

Model Number 201
Event Date 07/09/2008
Event Type Malfunction
Event Description
It was reported to manufacturer that the site was having problems interrogating vns patient's devices. Troubleshooting was performed, which included exchanging the 9v wand battery, and the problems did not resolve. The site requested a new programming wand to replaced the non-working device. Attempts to obtain additional information and the non-working device for analysis have been made, but have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1105286
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dennis100
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« Reply #41 on: January 31, 2017, 01:41:41 AM »

Model Number 201
Event Date 08/06/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that communication difficulties were experienced with a patient while trying to interrogate. The physician would receive a failure to communicate message on their handheld. They tried interrogating with the handheld plugged in and unplugged. The wand battery was good. All cables were secure and the wand was rotated. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1156188
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dennis100
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« Reply #42 on: January 31, 2017, 01:42:25 AM »

Model Number 201
Event Date 08/07/2008
Event Type Malfunction
Event Description
Reporter indicated a vns wand was not functional despite new batteries. The wand has been requested for return but has not been received to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1156170
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dennis100
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« Reply #43 on: January 31, 2017, 01:43:17 AM »

Model Number 201
Event Date 08/19/2008
Event Type Malfunction
Event Description
It was reported that the nurse practitioner obtained error messages on her handheld device. She returned both the handheld and programming wand to the manufacturer for analysis. After evaluating the handheld, no anomalies that support the reported complaint were observed so it was determined that the handheld device did not cause of contribute to the reported event. The programming wand was also evaluated and the issues reported by the nurse practitioner where confirmed. The cable was visually examined and no anomalies were identified. Additional analysis showed that the error originated in the serial data cable that had an intermittent conductor. The cable was replaced with a known good serial data cable and all the communication errors cleared. The wand with the new serial data cable passed all functional tests and was operating within the limits of the final electrical test requirements.

Manufacturer Narrative
Conclusions: 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=1172122
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dennis100
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« Reply #44 on: January 31, 2017, 01:44:21 AM »

Model Number 201
Event Date 01/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that a site's handheld would freeze at the interrogation screen and was never able to get past it. A replacement handheld was sent to the site and they were still not able to interrogate. They've only been able to interrogate successfully once. Troubleshooting was performed. The handheld was used unplugged, the programming wand battery was checked and they ensured there was no electromagnetic interference in the room. The nurse tried using another programming wand and this worked successfully. Product return and analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1105288
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dennis100
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« Reply #45 on: January 31, 2017, 01:45:09 AM »

Model Number 201
Event Date 08/01/2008
Event Type Malfunction
Event Description
It was reported to the manufacturer that the physician was experiencing issues with the programming system when interrogating the patient's device. The handheld had to be reset several times and there were long delays in receiving the interrogation results. A new handheld was sent to the site, per physician's request, as a replacement for the old handheld to help resolve the issue. The programming wand is suspected to be the problem component in the system as the event is likely due to a communication issue. Good faith attempts to confirm that the issue resolved after replacing the handheld are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1172154
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dennis100
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« Reply #46 on: January 31, 2017, 01:46:36 AM »

Model Number 201
Event Date 08/19/2008
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 nurse had difficulty programming a patient's device. She reported that while the power light in the programming wand was on and the data light was blinking, they could not get the wand to interrogate the patient's device. The battery was replaced and the issue continued. The nurse changed out the wand and the problem was resolved. The wand was returned to the manufacturer for analysis and reported event was confirmed. The cable was visually examined and no anomalies were identified. Additional analysis showed that the error originated in the serial data cable that had an intermittent conductor. The cable was replaced with a known good serial data cable and all the communication errors cleared. The wand with the new serial data cable passed all functional tests and was operating with the limits of the final electrical test requirements.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1172590
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dennis100
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« Reply #47 on: January 31, 2017, 01:47:43 AM »

Model Number 201
Event Date 07/01/2008
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
Initial reporter indicated that "their wand would not communicate; the battery was changed without any results. The wand was able to perform a test on a demo and everything was working perfectly" when he was in a different location. Good faith attempts are being made for the product to be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1084418
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dennis100
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« Reply #48 on: January 31, 2017, 01:51:28 AM »

Model Number 201
Event Date 07/02/2008
Event Type Malfunction
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death or serious injury.

Event Description
A manufacturer representative was at a physician's office to show him how to use the programming system. When she used her programming wand, the data received light on the handheld device would flash but the data would not go through. Troubleshooting steps were taken and the issue was not resolved. Product return is pending for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1085033
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dennis100
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« Reply #49 on: January 31, 2017, 01:52:44 AM »

Model Number 201
Event Date 07/01/2008
Event Type Malfunction
Event Description
Mfg consultant reported that she is having issues with her wand and states "it will not work unless she holds the wand cord against the wand. She has ruled out issues with the wand battery and would like us to send her a new wand. " the wand was returned for product analysis and there was a serial adapter/cord failure. The serial data cable, which produced communication errors, had an intermittent conductor. A known good bench serial data cable was substitute and all communications errors cleared. After the serial data cable was substituted, the wand passed functional test and it was verified through consistent communication of the wand. A serial adapter cord failure was the cause of the reported event.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1105863
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dennis100
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« Reply #50 on: February 01, 2017, 02:55:37 AM »

Model Number 201
Event Date 01/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

Event Description
Physician was unsuccessful trying to interrogate pt with their programming sys. A cyberonics' rep was present during this office visit. The rep tried using her own programming sys and was only able to successfully interrogate on a demonstration generator and not on the pt. Troubleshooting was performed. The handheld was not plugged into the wall, the battery on the programming wand was checked and ok. The wand was also rotated to see if communication could be meade. Physician was still receiving a communication failure message. A different programming wand was used and it was able to interrogate the pt successfully. Prod return is pending for prod analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1083152
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dennis100
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« Reply #51 on: February 01, 2017, 02:56:57 AM »

Model Number 201
Event Date 06/27/2008
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Rptr returned a vns programming wand because it was "old". There were no initial complaints against the wand. During the prod analysis, a failure to program issue was identified and confirmed. The serial data cable, which produced communication errors, had an intermittent conductor. A known good bench serial data cable was substituted and all communications errors cleared.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1083151
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dennis100
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« Reply #52 on: February 01, 2017, 02:58:43 AM »

Model Number 201
Event Date 06/01/2008
Event Type Malfunction
Event Description
Reporter indicated that communication could not be established with a test generator when using a site's programming wand. When another handheld computer was attached to the wand, communication still could not be established indicating that the wand was a likely source of the problem. The wand batteries were changed, connections were checked, and there was not believed to be any emi. The wand has been returned to the manufacturer for product analysis, and a new wand has been sent to the site.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1081943
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dennis100
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« Reply #53 on: February 01, 2017, 02:59:56 AM »

Model Number 201
Event Date 06/26/2008
Event Type Malfunction
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to death or serious injury.

Event Description
Reporter indicated that a site's programming wand had "a short in it" and was not working properly. It was reported that the battery was replaced, but the wand still would not work.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1182623
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dennis100
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« Reply #54 on: February 01, 2017, 03:01:18 AM »

Model Number 201
Event Date 06/01/2008
Event Type Malfunction
Event Description
Reporter indicated that the site experienced "communication problems" and received "error messages regarding inability to communicate with the device". It was reported that communication was possible when another programming wand was used.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1078848
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dennis100
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« Reply #55 on: February 01, 2017, 03:02:40 AM »

Model Number 201
Event Date 01/01/2008
Event Type Malfunction
Event Description
Reporter indicated that their current programming wand will not program. Troubleshooting steps were performed. Connections were checked, battery was replaced, tried different wall outlets and ensured there was no electromagnetic interference. Programming wand still didn't program. Physician used another wand and had no issues. Pending product return and analysis.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1076684
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dennis100
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« Reply #56 on: February 01, 2017, 03:03:36 AM »

Model Number 201
Event Date 01/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that he received an error message and was unable to use the programming system to program a patient's vns device. It was later reported that there was a "failure to interrogate". A new programming wand was sent to the site. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1076660
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« Reply #57 on: February 01, 2017, 03:04:30 AM »

Model Number 201
Event Date 01/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Nurse practitioner reported that she was unable to get the programming wand to communicate with pt's generators. Troubleshooting was performed and the batteries in the programming wand were changed. She was still unable to communicate. A replacement wand was sent to the site. Product return and analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1070418
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« Reply #58 on: February 01, 2017, 03:05:46 AM »

Model Number 201
Event Date 05/16/2008
Event Type Malfunction
Event Description
Reporter indicated a vns patient was unable to be interrogated. The pt's vns is implanted subpectorally. The pt has had a history of being difficult to interrogate due to the generator's positon but has been successfully interrogated in the past. Attempts for further info from the reporter have been unsuccessful to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1059923
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« Reply #59 on: February 01, 2017, 03:06:46 AM »

Model Number 201
Event Date 05/09/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a pt was unable to be interrogated with a vns wand and communication errors were received on the handheld computer. The wand has been requested for return. Attempts for further info are pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1057162
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