(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported by (b)(6) that during service and evaluation, it was observed that the power supply on the universal battery charger device was not functioning and defective.It was further determined that the left power supply showed smoke, power supply was defective, charging bay showed dent and was glued/taped from inside.It was noted in the service order that the device had two non-functional slots.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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