Model Number 5392 |
Device Problem
Failure of Device to Self-Test (2937)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 12/04/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that the external pulse generator (epg) displayed an error and the device was "not recoverable." the epg has been returned for servicing.There was no patient involvement.
|
|
Manufacturer Narrative
|
This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
|
|
Manufacturer Narrative
|
Product event summary: analysis confirmed the reported event, the main printed circuit board (pcb) was out of electrical specification.It was also noted that the display wires were pinched.
|
|
Manufacturer Narrative
|
Further analysis was performed on the main board.Visual inspection revealed no anomalies.Bench analysis found that all tests passed.The log was also analyzed.The device had a normal power-up, during a scheduled battery/super cap measurement the super cap measured high which caused an error.The next power up cycle caused the displayed error to occur.Conclusion: it was confirmed by log analysis that an error for super cap high triggered out of service error, however the error was not reproducible in analysis.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|