Additional information was received, indicating there was no patient injury.(updated h6 event, problem patient code).Device evaluation: one device was returned for analysis in used condition.Visual inspection showed, a non-original equipment manufacturer case and super capacitor on the main board, the bottom case was cracked by the l-bracket and right plunger case.And the plunger case seal was missing.During functional testing, the reported issue was not duplicated.However, the investigation determined that a possible, but unconfirmed, cause of the reported issue was the non-original equipment manufacturer super capacitor.A manufacturing dhr review was not performed, because the results of the complaint investigation do not indicate, a problem with the manufacture of the device.
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