DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The full event site name is (b)(6).A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.However, the fse was able to verify in the unit's logs that the fault occurred.The fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to clinical service.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had a gas leak issue.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, g4, g7, h2, h6(evaluation method codes), h10, h11.Corrected fields: h6(evaluation conclusion code).
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had a gas leak issue.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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Search Alerts/Recalls
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