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Model Number N/A |
Device Problem
Failure to Calibrate (2440)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the 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 was unable to reproduce the reported issue.The fse had spoken with staff and they reported to the fse that they had the iabp set in pressure mode, so he reviewed the logs and no error alarms were present.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.
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Event Description
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It was reported that during use on a patient, the fiber optics of the cardiosave intra-aortic balloon pump (iabp) were not calibrating and the iabp was slow to start pumping.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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