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 08/16/2023 |
Event Type
malfunction
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Event Description
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It was reported that during preventative maintenance by getinge field service engineer, the cs300 intra-aortic balloon pump (iabp) unit had battery run time test failure.System shutdown at 98min below the acceptable min.Time of 135min.There was no patient involvement.
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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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Manufacturer Narrative
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To fix the issue, the getinge field service engineer (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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