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.The getinge fse that encounter the issue, removed and replaced the coil cable, and performed all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.Pm was completed and the iabp was then released to the customer and cleared for clinical service.(b)(6).
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It was reported that while performing a scheduled preventive maintenance (pm) performed by a getinge field service engineer (fse), it was discovered that the coiled cable of the cardiosave intra-aortic balloon pump (iabp) had a faulty connector that could allow it to inadvertently become detached from the top of the iabp console.There was no patient involvement, and no adverse event reported.
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