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
Premature Discharge of Battery (1057)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/16/2023 |
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 during preventive maintenance by getinge field service engineer, the cs300 intra-aortic balloon pump (iabp) unit's battery run test failed.There was no patient involvement.
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Manufacturer Narrative
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To fix the issue, the fse replaced the batteries.The fse then completed the pm with all functional and safety tests to factory specifications.The unit was returned to the customer.
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Search Alerts/Recalls
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