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.A getinge field service engineer (fse) evaluated the iabp and reported no problems were found during the evaluation of the iabp.Fse completed pm with full calibration, functional testing and safety check to factory specifications.The iabp passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.
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