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Model Number N/A |
Device Problem
Circuit Failure (1089)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/08/2018 |
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) 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, tested the iabp, checked the power supply as per calibration, and the iabp passed all voltage checks.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 while patient transport, when the cs300 intra-aortic balloon pump (iabp) was plugged into the ambulance circuit board, it popped a fuse.There was a power surge in the ambulance.The customer requested the iabp to be checked out for damage.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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