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 08/22/2023 |
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 batteries did not last long enough for pm.There was no patient involvement reported.
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Event Description
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N/a.
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Manufacturer Narrative
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To fix the issue, the getinge field safety 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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