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 service territory manager (stm) who encountered the issue isolated the failure to the front end circuit.To address the issue the stm replaced the front end circuit and performed 30psi calibration as per service manual.The stm completed the pm and performed all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.(b)(6).
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