This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Product event summary: the battery charger and battery charger ac adapter were returned for evaluation.A review of the battery charger manufacturing documentation confirmed that the associated device met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the battery charger ac adapter revealed that the unit passed visual and functional testing.As a result, the reported "battery charger ac adaptor no power" event was not confirmed.Failure analysis of the returned battery charger revealed that the unit passed visual inspection.Functional testing revealed that two led status indicators were inoperable.Supplemental testing revealed damaged leds.It was determined that the battery charger was assembled with an incorrect inductor, damaging the led indicators.As a result, the reported "not charging" event could not be confirmed.However, the damaged leds were most likely perceived by the patient as the reported not charging.The most likely root cause of the reported "battery charger ac adaptor no power" event can be attributed to multiple factors, including but not limited to a marginal connection between the adapter and the battery charger and/or a marginal connection between the adapter and the wall outlet.The most likely root cause of the reported "battery charger not charging" event can be attributed to improper assembly.An internal investigation was initiated to investigate battery chargers assembled with incorrect inductors.If information is provided in the future, a supplemental report will be issued.
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