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
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2021 |
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) displayed catheter not connected messages.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to investigate to evaluate the unit.The fse tested the iabp unit with a balloon and system trainer, but was unable to reproduce the reported issue.However, the fse discovered four "check iab catheter" alarms in the logs to have occurred on (b)(6) 2021.The fse performed functional and safety checks to meet 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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Manufacturer Narrative
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Updated fields; b4, e2, e3, g3, g6, g7, h2, h4, h6, h10.
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Search Alerts/Recalls
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