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 Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2024 |
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) failed battery run test and pneumatics performance test.There was no patient involvement.
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Manufacturer Narrative
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The fse that encountered the issue replaced batteries (0146-00-0039) and installed 5000 hour pm kit (0040-00-0146).The device passed all functional and safety tests according to factory specifications.The device was returned to the customer.
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Event Description
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N/a.
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Search Alerts/Recalls
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