DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-55 |
Device Problem
Failure to Run on Battery (1466)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2021 |
Event Type
malfunction
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Event Description
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It was reported that during routine check, the cs300 intra-aortic balloon pump (iabp) would not working on batteries and needed to be replaced.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.The fse determined that batteries were defective and needed to be replaced.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, g7, h2, h4, h6, h10.
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Event Description
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N/a.
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Search Alerts/Recalls
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