One controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event of "faulty display".The reported event, "faulty display", could not be confirmed.Analysis of the device revealed that the controller met specifications; the device passed functional testing.The characters, back light and led indicators were functioning as expected when the display was evaluated.No failure detected, the reported event could not be duplicated at the bench level.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
|