(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 reported condition was confirmed.It was also observed that the housing damaged dent groves.The assignable root cause was determined to be due to faulty/improper handling.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
It was reported from (b)(6) that during service and evaluation, it was observed that the housing on the universal battery charger device was broken and deformed.It was further noted that the device did not function, the fan vent was broken, the device had a bent foot; and the housing was badly scratched and had bumps.It was noted in the service order that the charger had an internal short circuit.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.
|