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Catalog Number 05.001.202 |
Device Problems
Bent (1059); Break (1069); Component Falling (1105)
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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).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 device was damaged by dropping.Therefore, the reported condition was confirmed.It was further determined that the led lights were up, there was buckling in the groove behind the bracket and the bracket was bent.The assignable root cause was determined to be due to improper handling.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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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 power module device was damaged by dropping.It was further determined that the device had led lights that were up, buckling in the groove behind the bracket, a bent bracket and a fall damage.It was noticed in the service order that the device was not working.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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Search Alerts/Recalls
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