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); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2024 |
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 while a getinge representative was performing service on the cardiosave intra-aortic balloon pump (iabp) for an unrelated reason, the iabp would not pass the pim leak test, the pim required replacement, and the ground lead on the power cord had an intermittent break that required replacement.There was no patient involvement.
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