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Author Topic: Handheld Computer/Programming Wand  (Read 278755 times)
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dennis100
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« on: January 30, 2017, 08:37:14 AM »

Model Number 201
Event Date 10/02/2008
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported to the manufacturer that the programming wand was not establishing communication with patient's generator. Troubleshooting did not resolve the issue. Issues with patient's generators have been ruled out as a back system was used immediately which resolved the communication issues and the patient's generator was successfully programmed. A replacement wand was sent to the site which had no further issues and the defective wand was returned to the manufacturer for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1220044
« Last Edit: April 28, 2017, 12:56:31 AM by dennis100 » Logged
dennis100
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« Reply #1 on: January 30, 2017, 08:38:09 AM »

Model Number 201
Event Date 08/06/2008
Event Type Malfunction
Event Description
It was reported to a mfr consultant that the physician had a programming wand that was not "working". The wand was returned for product analysis. 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. After the serial data cable was substituted, the programming wand was electrically tested and was operating within the designed limits of the final electrical test requirements.

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=1193200
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dennis100
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« Reply #2 on: January 30, 2017, 08:38:52 AM »

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

Event Description
Reporter indicated a vns wand was not communicating despite changing the wand battery. The wand was returned for analysis. Product analysis noted that the serial data cable, which produced communication errors, had open and intermittent conductors. 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=1204676
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dennis100
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« Reply #3 on: January 30, 2017, 08:39:33 AM »

Model Number 201
Event Date 09/19/2008
Event Type Malfunction
Event Description
Initial reporter indicated that they were having "some problems with their programming wand". Good faith attempts are being made for additional details about the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1203390
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dennis100
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« Reply #4 on: January 30, 2017, 08:40:24 AM »

Model Number 201
Event Date 08/28/2008
Event Type Malfunction
Event Description
Reference mdr number 1644487-2008-02341. Product returned with a handheld and programming software. Product analysis was performed on the returned programming wand. The serial data cable, which produced communication errors, had an intermittent conductor and the returned battery was depleted. A known good bench serial data cable and the battery were substituted. All communications errors cleared. Root cause for a complaint alleging a non-functional programming wand is the depleted battery. This could be attributed to user oversight or possibly not knowing that the battery needs to be replaced on occasion. After the serial data cable and the battery were substituted, passing functional test results verified consistent communication of the wand. After the serial data cable was substituted, the programming wand was electrically tested and was operating within the designed limits of the final electrical test requirements. No visual anomaly was identified. Continuity testing of the battery cable passed.

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=1198388
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dennis100
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« Reply #5 on: January 30, 2017, 08:41:14 AM »

Model Number 201
Event Date 09/04/2008
Event Type Malfunction
Event Description
It was reported that a vns patient came to the office and communication difficulties were experienced during a programming session. The physician was trying to program the generator back to the patient's intended settings but was unable to do so (refer to mfg report no. 1644487-2008-02389 for the programming anomaly event). Troubleshooting was performed which resolved the issue after several tries. When the physician tried to perform diagnostics on the patient's device, the error message "generator failed to respond to initial programming" appeared several times. Good faith attempts to obtain additional info regarding this reported event are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1188724
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dennis100
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« Reply #6 on: January 30, 2017, 08:42:12 AM »

Model Number 201
Event Date 09/02/2008
Event Type Malfunction
Event Description
Reporter indicated that a programming wand was not working properly. Communication errors were observed. The physician could not get the wand to work when he held the cable a certain way. The wand battery was replaced, and the site could not get the green light to come on when performing the battery test. A new wand was sent to the site. Good faith attempts to obtain the old wand for analysis 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=1188723
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dennis100
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« Reply #7 on: January 30, 2017, 08:42:59 AM »

Model Number 201
Event Date 09/03/2008
Event Type Malfunction
Event Description
It was reported that a cyberonics rep was unable to get his wand to work. He performed routine troubleshooting and changed the battery; however, the wand would not work. He used a different programming system and everything worked fine. He also used his handheld device with a different wand and everything worked fine. The product has been received by the mfr for analysis; however, it has not been completed at the time of this report.

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=1191917
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dennis100
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« Reply #8 on: January 30, 2017, 08:43:42 AM »

Model Number 201
Event Date 01/01/2008
Event Type Malfunction
Event Description
No problems were noted prior to return of device, but wand was returned to mfr and underwent product analysis. Upon analysis, it was discovered that the serial data cable had open and intermittent conductors which caused communication errors. Serial data cable was replaced with known good bench cable and all communication errors cleared. Everything else was operating within normal limits and no visual anomalies were observed.

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=1191906
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dennis100
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« Reply #9 on: January 30, 2017, 08:44:33 AM »

Model Number 201
Event Date 09/04/2008
Event Type Malfunction
Event Description
It was reported to mfr that the physicians programming system was not working and a replacement was requested. Troubleshooting was performed and despite having replaced the wand battery with a known good 9v battery, communication could not be established with a demo generator using two different known working handhelds. The non-working programming wand has been returned to mfr and analysis is underway.

Manufacturer Narrative
Conclusions: device failure is suspected, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1188719
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dennis100
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« Reply #10 on: January 30, 2017, 08:45:15 AM »

Model Number 201
Event Date 09/29/2008
Event Type Malfunction
Event Description
Reporter indicated a vns programming wand worked intermittently. The wand was returned to the manufacturer and analysis confirmed the event. The reset switch was stuck in the on state, which prevented device communication.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1216052
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dennis100
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« Reply #11 on: January 30, 2017, 08:46:03 AM »

Model Number 201
Event Date 10/04/2008
Event Type Malfunction
Event Description
It was reported that a physician was receiving an error message whenever she tried to use her programming wand. A manufacturer representative was present, switched out wands, and the issue resolved. Routine troubleshooting was performed however, the error message was still present. The physician's wand was replaced and sent back to the manufacturer for analysis. The evaluation of the returned device has not been completed at the time of this report.

Manufacturer Narrative
Conclusions: device failure 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=1216047
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dennis100
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« Reply #12 on: January 30, 2017, 08:46:45 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 a vns wand failed to program. The wand has been returned and is currently in product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1236138
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dennis100
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« Reply #13 on: January 30, 2017, 08:47:41 AM »

Model Number 201
Event Date 09/26/2008
Event Type Malfunction
Event Description
It was reported that a programming wand would not interrogate a patient's vns device. Troubleshooting and changing the battery did not resolve the issue. A different programming wand was used to successfully interrogate the patient's device. The wand was sent to the manufacturer for analysis. Product analysis revealed that the serial data cable had intermittent conductors which produced 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=1236235
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dennis100
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« Reply #14 on: January 30, 2017, 08:48:33 AM »

Model Number 201
Event Date 01/01/2008
Event Type Malfunction
Event Description
Reporter indicated that the programming wand did not work. Troubleshooting was done by manufacturer representative and wand still would not work. Products have been requested, but have not been returned to manufacturer to date.

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1236210
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dennis100
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« Reply #15 on: January 30, 2017, 08:49:26 AM »

Model Number 201
Event Date 10/01/2008
Event Type Malfunction
Event Description
Initial reporter indicated that their handheld was giving a failure message. The programming wand was not communicating and "taking forever trying to establish communication. " the programming wand was returned for product analysis. The reported issue, failure to program, was confirmed. The serial data cable, which produced communication errors, had intermittent conductors. A known good bench serial data cable was substituted and a known good bench battery was installed and all communication errors cleared.

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=1236206
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dennis100
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« Reply #16 on: January 30, 2017, 08:50:16 AM »

Model Number 201
Event Date 10/13/2008
Event Type Malfunction
Manufacturer Narrative
Device malfunction caused event, but did not contribute to a death or serious injury.

Event Description
Initial reporter indicated that their programming wand would not interrogate a demo generator. Another wand was able to get the demo generator interrogated. The programming wand was returned for analysis. The reported issue, failure to program, was 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=1236205
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dennis100
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« Reply #17 on: January 30, 2017, 08:51:14 AM »

Model Number 201
Event Date 09/08/2008
Event Type Malfunction
Event Description
Initial reporter indicated that their programming wand was getting the error message "error establishing communication. " the battery in the wand was checked and it was "fine" and the programming system was not plugged into the wall. The wand is at manufacture pending completion of product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1190683
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dennis100
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« Reply #18 on: January 30, 2017, 08:52:01 AM »

Model Number 201
Event Date 09/02/2008
Event Type Malfunction
Event Description
Initial reporter indicated that they were told by a physician "that they were having some issues with their programming wand. Batteries were changed without results. Another wand was used and everything worked perfectly. " the programming wand is being sent to manufacturer for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1190594
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dennis100
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« Reply #19 on: January 30, 2017, 08:52:54 AM »

Model Number 201
Event Date 08/25/2008
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 a vns wand failed to program pts. The wand has been requested for return but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1186530
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dennis100
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« Reply #20 on: January 31, 2017, 01:24:20 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 reported that their programming wand was not working. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1133177
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dennis100
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« Reply #21 on: January 31, 2017, 01:25:15 AM »

Model Number 201
Event Date 08/27/2008
Event Type Malfunction
Manufacturer Narrative
(see scanned page).

Event Description
Reporter indicated a vns programming wand was working intermittently. 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=1191540
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dennis100
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« Reply #22 on: January 31, 2017, 01:26:02 AM »

Model Number 201
Event Date 07/29/2008
Event Type Malfunction
Event Description
Initial reporter indicated to a therapeutic consultant that they received an error message on their programming wand "failed to receive model id". The patient seen was seen two months prior and "everything was fine". The patient was not at the office at the time, the event was reported to the consultant. Good faith attempts are being made for additional details surrounding the event. At this time, the event is believed to be related to the programming wand.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1145492
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dennis100
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« Reply #23 on: January 31, 2017, 01:26:57 AM »

Model Number 201
Event Date 08/28/2008
Event Type Malfunction
Event Description
It was reported that a programming wand was not working properly due to a "cinched" cord. The site does not know the cause for the "cinched" cord. A new wand was sent to the site, and the old wand has been returned to the manufacturer for 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=1191503
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dennis100
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« Reply #24 on: January 31, 2017, 01:27:38 AM »

Model Number 201
Event Date 01/01/2008
Event Type Malfunction
Event Description
Reporter indicated not being able to communicate with a vns patient's generator. During communication, orange light on the wand is on for "one sec and then nothing further. " multiple attempts were unsuccessful. Troubleshooting did not resolve the issue. The handheld has been used successfully on other patients without any problem. 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=1133176
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dennis100
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« Reply #25 on: January 31, 2017, 01:28:16 AM »

Model Number 201
Event Date 08/27/2008
Event Type Malfunction
Event Description
It was reported that the physician had difficulty interrogating the pt's device during a routine programming session. The physician performed troubleshooting and was unable to resolve the issue. The site has had similar problems in the past when they used the same wand with different handheld devices on various pts. Good faith attempts to obtain additional info and product for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1181597
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dennis100
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« Reply #26 on: January 31, 2017, 01:29:04 AM »

Model Number 201
Event Date 08/01/2008
Event Type Malfunction
Event Description
Reporter indicated that site was having problems with the communication between their handheld computer and the interrogating wand. Manufacturer rep tested the system and found it to be the wand that was not working properly. Product has been returned to manufacturer, but product analysis is pending.

Manufacturer Narrative
Device malfunction is supected, 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=1181365
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dennis100
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« Reply #27 on: January 31, 2017, 01:29:48 AM »

Model Number 201
Event Date 08/21/2008
Event Type Malfunction
Event Description
The reporter indicated that the green "power" light was on a vns programming wand would not illuminate even after performing basic troubleshooting steps. The programming wand was returned to the manufacturer and is currently awaiting 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=1172610
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dennis100
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« Reply #28 on: January 31, 2017, 01:30:35 AM »

Model Number 201
Event Date 08/22/2008
Event Type Malfunction
Event Description
Reporter indicated a vns therapy handheld programming system received a "failure to establish communication" error message. The programming system has been returned to the manufacturer is pending product analysis.

Manufacturer Narrative
Device malfunction 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=1172587
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dennis100
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« Reply #29 on: January 31, 2017, 01:31:23 AM »

Model Number 201
Event Date 08/27/2008
Event Type Malfunction
Event Description
The reporter indicated that he was experiencing communication errors with his vns programming wand. The wand was returned to the mfr and the reported event was verified as the serial cable was found to have an intermittent conductor, thus causing the communication issues. After substituting a known good bench cable, the device performed according to specs.

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=1157595
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