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 during the pm, the unit failed to meet the minimum battery run time specification.To fix this issue, the stm replaced both batteries with the new original equipment manufacturer (oem) parts.The stm performed complete pm with full calibration, functional testing and safety checks per factory specifications.This unit has been returned to the customer and cleared for clinical use.(b)(6).
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