Model Number N/A |
Device Problem
Output Problem (3005)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted when this information is provided to us.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) has a low vacuum error.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, h2, h6 (type of investigation), h10.
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Event Description
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It was reported that during a routine check performed by the customer, the cardiosave intra-aortic balloon pump (iabp) has a low vacuum error.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The problem was found with the drive manifold which was replaced, and the iabp was then put under observation.There were no issues after the replacement of the part, so the fse 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 a routine check performed by the customer, the cardiosave intra-aortic balloon pump (iabp) has a low vacuum error.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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