DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problem
Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) vacuum pump was low.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and found that the iab fill port hose was cut with something sharp.To fix the issue, the fse removed a small piece of the hose and reattached it, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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N/a.
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Search Alerts/Recalls
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