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
Failure to Charge (1085); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2023 |
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 safety disk is failing testing.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated data: b4, g3, g6, h2, h10, h11.
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Event Description
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It was reported that during preventative maintenance by getinge field service engineer, the cardiosave intra-aortic balloon pump (iabp) was not charging batteries and the safety disk was failing the pneumatic interface module test.There was no patient involvement.
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Search Alerts/Recalls
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