DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-55 |
Device Problem
Calibration Problem (2890)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/17/2024 |
Event Type
malfunction
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Event Description
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It was reported that, the cardiosave intra-aortic balloon pump (iabp) units fiber optics can not be calibrated.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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Corrected data: b5.Updated data: b4, g3, g6, h2, h10, h11.
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Event Description
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It was reported that by the client, the cardiosave intra-aortic balloon pump (iabp) units fiber optics can not be calibrated.
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