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.Due to the run time failure of the batteries, and also the observation that the batteries were due to expire in march 2018, the getinge stm replaced the batteries.In addition, all functional and safety checks were performed to meet factory specifications, and full pm was completed.The iabp passed all functional and safety test per factory specifications and was released to the customer for return to clinical service.
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