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 Problems
Break (1069); Failure to Sense (1559); Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to confirm that the iabp was giving a fiber optic error.He discovered that the fiber optic connection and the blue clip were cracked.To fix the issue, the fse replaced the fiber optic connection and performed all functional and safety checks to meet factory specifications.Unit passed all 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 there was a fiber optic sensor failure due to a damaged fiber optic sensor connection point on the cardiosave intra-aortic balloon pump (iabp).No patient harm, serious injury or adverse event was reported.
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Event Description
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N/a.
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Manufacturer Narrative
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Corrected fields: e1 (event site email), h6 (medical device ¿ problem code).
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Manufacturer Narrative
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Updated fields: b4, g4, g7, g8, h2, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: b5, b6, b7, g1(contact person).
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Event Description
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It was reported that during use there was a fiber optic sensor failure due to a damaged fiber optic sensor connection point on the cardiosave intra-aortic balloon pump (iabp).No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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