(b)(4).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 replaced the safety disk due to hour usage.Fse tested the fiber optics assembly and verified that the signal was not being sent.Fse replaced the fiber optics assembly and after completing the tests, he was able to confirm that the low level signal was good.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.
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