This report was identified as part of the remediation effort reviewed with the fda center of philadelphia and orlando districts on 3/30/2016.This 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/faulty care and maintenance, which is user error, misuse, and / or abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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It was reported from (b)(6) that during service and repair, it was observed that the power module device housing was open and there was heat damage on the sealing film.This event was not related to surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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