The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The fiber optic connector on the iabp console was damaged.To fix the issue, the fse replaced the fiber optic sensor extension cable assembly.The safety disk was also replaced because it was expired.The customer requested a new style ecg trunk cable so it was supplied as well.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.The full event site name is (b)(6).
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