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 09/14/2023 |
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 (pm) performed by a getinge service territory manager (stm) , the cs300 intra-aortic balloon pump (iabp) unit failed battery run test.There was no patient involvement.
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Manufacturer Narrative
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The fse replaced the batteries to fix the issue.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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Event Description
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N/a.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated data: b3,b4,g3,g6,h2,h10,h11.
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Search Alerts/Recalls
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