The reported event of a faulty display on the returned controller, (b)(4), could not be confirmed.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The unit was sent to the supplier, where analysis of the device revealed that the device met specifications; the device passed visual examination and functional testing.The liquid crystal display (lcd) performed as expected.Additionally, the leds were all functional.As a result, the reported event could not be confirmed; the device passed visual and functional testing.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.
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