Model Number 0998-00-0800-55 |
Device Problems
Leak/Splash (1354); Gas/Air Leak (2946); Insufficient Information (3190)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2023 |
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 inhouse repairs.
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Event Description
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It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit has inhouse repairs for helium leak.
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Manufacturer Narrative
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Corrected data: b5, h6 (problem code).Updated data: b4, e1(initial reporter), e2, e3, g2, g3, g6, h2, h10, h11.
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Event Description
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It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) unit has inhouse repairs for helium leak.There was no patient involved.
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Manufacturer Narrative
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It was reported that the cardiosave intra-aortic balloon pump (iabp) helium leak.Getinge field service engineer (fse) the problem was confirmed directly in the laboratory.Work performed: disassembly of the crankcase, replacement of the complete fill manifold.Functional checks and diagnostic tests.Preventive replacement of the o-ring connection between the trolley and the console carried out.Regular functioning tests.Final result: repair completed.The device has passed all performance and safety tests according to the parent company's specifications.No patient involved.
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Search Alerts/Recalls
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