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 during initial testing he observed maintenance required code #3.The fse observed atmospheric and shuttle transducers were out of calibration, and could not recalibrate the transducers.The fse isolated the issue to a defective front end board.The fse installed a new front end board and fully calibrated it to specifications.This corrected the atmospheric and shuttle calibration failure.The fse completed the preventive maintenance with full calibration, functional testing and safety check to factory specifications.The iabp passed all functional and safety tests per factory specifications and was returned to customer, cleared for clinical use.(b)(6).
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