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Device Problem
Gas/Air Leak (2946)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2023 |
Event Type
malfunction
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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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Event Description
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It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit has gas leaks from the regulator when the he gas cylinder is opened.
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Manufacturer Narrative
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Corrected data: b5, b6, b7, d10, h6 (clinical and impact code).Updated data: b4, g3, g6, h2, h10, h11.
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Event Description
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It was reported that before use, pre-use inspection by hospital staff, the cardiosave intra-aortic balloon pump (iabp) unit has gas leaks from the regulator when the he gas cylinder is opened.There was no patient involved.
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Search Alerts/Recalls
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