Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/26/2018 |
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) 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 was able to reproduce the reported issue.The fiber optic sensor connection was misaligned.The fse replaced the fiber optic connection and performed full functional check out.The iabp passed all functional and safety checks to meet 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 the cardiosave intra-aortic balloon pump (iabp) fiber optic connector was not functional.The iabp was replaced with another cardiosave.There was no patient involvement or adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp and was able to reproduce the reported issue.The fiber optic sensor connector was misaligned due to a bent and broken connector.The fse replaced the fiber optic connector and performed full functional checkout.The iabp passed all functional and safety checks to meet 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 the cardiosave intra-aortic balloon pump (iabp) fiber optic connector was not functional.The iabp was replaced with another cardiosave.There was no patient involvement or adverse event reported.
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Search Alerts/Recalls
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