The production device history record (dhr) for this intra-aortic balloon pump (iabp) is 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 field service engineer (fse) was dispatched and reported that he verified autofill failures occurred in the event log but was unable to duplicate any failures.The fse performed a complete preventive maintenance with full calibration functional testing, and safety check to factory specification.The iabp passed all functional and safety tests per factory specifications, and was returned to the customer, cleared for clinical use.
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