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.The getinge field service engineer reported that the batteries failed the runtime test.The battery runtime was 98 minutes, and the minimum runtime specification is 135 minutes.The fse replaced the batteries, as well as, performed all functional and safety checks to factory specifications.The iabp was returned to the customer and cleared for clinical use.
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