Catalog Number 05.001.204 |
Device Problems
Failure of Device to Self-Test (2937); Flare or Flash (2942)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was observed that the blue light emitting diode (led) was flashing on the universal battery charger device.It was further determined that the device failed the self-test.It was noted in the service order that the device was functionless and the blue led flashed.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the blue led was flashing and the device failed self-test.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to strain/wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Search Alerts/Recalls
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