The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.(b)(6).A getinge service territory manager (stm) evaluated the iabp and verified in the fault logs that the iabp shutdown occurred while switching from battery 1 to battery 2 in rescue mode.The stm removed the batteries one at a time while running the iabp.He was unable to duplicate the alleged shut down.The iabp switches between batteries.The stm replaced suspect power management board and verified the iabp was calibrated and passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.
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