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 confirmed error code 47 for balloon inflation.In addition the iabp failed the drive manifold vacuum test, to address the issue the stm replaced the helium fill assembly.The stm additionally replaced the scroll compressor due to the amount of noise while running.The stm ran the unit on a trainer with a test balloon.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.Full event site name: (b)(4).
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