DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The getinge field service engineer (fse) that encountered the issue discovered the iab connector on the pim assembly was cracked.To fix the issue, the fse replaced the pneumatic module assembly and completed the 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 preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) failed the pim leak 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 preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) failed the pim leak test.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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(b)(6).
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Search Alerts/Recalls
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