DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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During a preventative maintenance (pm) service, the getinge field service engineer (fse) found fault codes 111 and 112 in the unit's logs.Upon inspecting the iabp unit, the fse found that the connector swiveled too much, thereby damaged.To fix the issue, the fse replaced the coiled cable cord, and then completed a full pm service.The fse also performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.(b)(6).
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the fse found that the coiled cable of the cardiosave intra-aortic balloon pump (iabp) was damaged and produced fault codes 111 and 112 which was found in the unit's logs.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the fse found that the coiled cable of the cardiosave intra-aortic balloon pump (iabp) was damaged and produced fault codes 111 and 112 which was found in the unit's logs.There was no patient involvement, and no adverse event reported.
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