DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Failure to Sense (1559)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge service territory manager (stm) was dispatched to investigate the triggering issue and was not able to reproduced it.The stm performed functional testes without any issue.No problem found.Cardiosave iabp services was completed.Safety, calibration, and functionality checks passed as per factory specifications.The iabp was returned to the customer and cleared for clinical use.
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Event Description
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It was reported that during use the cardiosave intra-aortic balloon pump (iabp) stopped trigging.There was no harm or injury to the patient and no adverse event was reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h4, h6, h10.
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Event Description
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N/a.
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Search Alerts/Recalls
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