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 was returned for evaluation.A review of the 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 device in relation to the reported event.Failure analysis of the returned battery charger revealed that the unit passed visual inspection.Functional testing revealed that a charging port was unable to charge a battery.Supplemental testing revealed a damaged fuse and fet in the charging circuit.It was determined that the battery charger was assembled with incorrect inductors, resulting in damaged components.As a result, the reported event was confirmed.The most likely root cause of the reported 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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