(b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device led light was illuminated and the device did not function.The device also failed pretest for refresh, charging function, charger self-check, power-on test and software revision.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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It was reported from the (b)(6) that there was smoke coming out of the universal battery charger device.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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