The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.To address the failure, the fse replaced the helium regulator assembly and performed a complete pm with functional checks.The iabp unit passed all functional and safety checks to meet factory specifications.The unit was returned to the customer and cleared for clinical use.(b)(6).
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