The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to evaluate the iabp.The stm studied and research the iabp's logs; the power activity logs show low battery percentages for battery one (1) and two (2) around when the unit was being ran on battery, shutting down shortly after.The iabp powered back on ac to continue treatment without issue.The facility's biomedical engineer indicated that the change nurse relayed that the iabp may have been unplugged at time of incident.The stm stated that nothing else unusual showed in the logs.The stm additionally reported that battery runtime test on battery two (2) was tested with full battery and it showed less than five (5) minute charge a minute after starting test.The stm indicated that around 32 minutes.Battery two showed three leds of charge, clearing low battery alarm, continuing to run to seventy minutes without issue.The stm reported that the battery charge was incorrectly shown for battery two upon initial testing.To fix this issue the stm order and replaced both batteries as a pair and physically observed that the batteries were charging.All functional and safety tests were performed and passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
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