DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID DOMESTIC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Inability to Auto-Fill (1044)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The iabp would not auto-fill, failed the leak test, and failed compressor regulator calibration.To fix the issue, the fse replaced the scroll compressor.Full calibration, functional, and safety checks were performed, which passed to meet factory specifications.The iabp was then released to the customer, and cleared for clinical service.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) unit would not fill.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Event Description
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It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) unit would not fill.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) unit would not fill.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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