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 evaluated the iabp and was not able to duplicate the alleged malfunction.The iabp passed all functional and safety tests per factory specifications, was returned to customer, and cleared for clinical use.The complete event site name is "(b)(6)".
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