DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The stm removed and reseated the safety disk and performed the leak test which failed the membrane leak test again.The stm replaced the safety disk which then passed all leak tests.The stm completed pm service including all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.The suspected faulty safety disk has been requested to be returned for failure investigation.A supplemental report will be submitted when additional information is provided.
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm), the new safety ,disk installed in the cardiosave intra-aortic balloon pump (iabp) failed the membrane leak test.There was no patient involvement, and no adverse event reported.
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Event Description
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N/a.
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Search Alerts/Recalls
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