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
Failure to Run on Battery (1466)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and was able to reproduce the reported issue.Specifically, while ensuring the unit functioned properly, the unit shut off on it's own.The fse resolved the issue by replacing the batteries.The fse performed functional and safety checks to meet factory specifications.Moreover, the fse advised the customer to let the unit charge overnight to ensure the batteries charge properly.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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It was reported that the cs300 intra-aortic balloon pump (iabp) required battery replacement, causing the unit shutting off during a walk with a patient, as a result of no battery power.No patient harm, serious injury or adverse event was reported.
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Event Description
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It was reported that during patient transport the cs300 intra-aortic balloon pump (iabp) required battery replacement, causing the unit shutting off during a walk with a patient, as a result of no battery power.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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