DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/10/2020 |
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) discovered that iabp unit failed the drive manifold test.To fix the issue, the fse installed a new drive manifold, and performed drive manifolds test.The iabp unit passed all tests and pre-use checks.The fse then completed a full calibration, as well as all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to 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 cardiosave intra-aortic balloon pump (iabp) failed the drive manifold test.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 cardiosave intra-aortic balloon pump (iabp) failed the drive manifold test.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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