DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-58 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
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 cs300 intra-aortic balloon pump (iabp) units self fill connection is broken.
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Manufacturer Narrative
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Updated data: b4,g3,g6,h2,h10,h11 corrected data: b5,b6,b7,d10,h6(clinical & impact).
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Event Description
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It was reported that prior to use, the cs300 intra-aortic balloon pump (iabp) units self fill connection is broken.There was no patient involvement.
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Event Description
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N/a.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate the issue.In order to fix the issue, the fse replaced the connectors.All functional and safety checks to meet factory specifications performed.The unit was the suitable for clinical use.
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Search Alerts/Recalls
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