DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A getinge field service engineer (fse) evaluated the iabp unit and found error logs pertaining to the compressor and the 8k valve, and the compressor would not supply enough pressure.The fse replaced the drive manifold assembly and scroll compressor, and completed a pm with full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, 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 cardiosave intra-aortic balloon pump (iabp) had autofill errors.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h6 (evaluation method codes), h10, h11.Corrected field: d1.
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Event Description
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It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had autofill errors.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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