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 Problem
No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
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 , the cardiosave intra-aortic balloon pump (iabp) printer does not work intermittently.There was no harm reported.
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Event Description
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It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) printer does not work intermittently.There was no harm reported.
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Manufacturer Narrative
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Updated data: b4, g3, g6, h2, h10, h11.
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Manufacturer Narrative
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A getinge field service engineer (fse) stated after evaluating the unit and confirming the issue, the printer was replaced.The fse performed a full calibration, and tested the unit.The product passed all functional/safety testing and was returned to the customer.
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Search Alerts/Recalls
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