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 charging port one (1) was unable to charge a battery.Additionally, the led status indicator on charger bay three (3) and four (4) were inoperable.Supplemental testing revealed a damaged fet in the charging circuit and damaged leds on the led circuit.It was determined that the battery charger was assembled with an incorrect inductor, resulting in damaged components.The incorrect inductors might over charge a battery, causing the battery to flash red on the battery charger due to an eight (8) hour charge time-out.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed 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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