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
Gas/Air Leak (2946)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2024 |
Event Type
malfunction
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Event Description
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It was reported that, the cs300 intra-aortic balloon pump (iabp) had an air and gas leak.
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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 prior to use, the cs300 intra-aortic balloon pump (iabp) had an air and gas leak.There was no patient involvement.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate the issue.The fse replaced solenoid driver to resolve issue.Also, due to intermittent power and for precautionary reasons, the fse replaced the cable assembly.The fse performed a full calibration, and tested the unit.The equipment works to manufacture¿s specs and passed all functional and safety test.The unit was returned to the customer.
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