DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-58 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that , the cs300 intra-aortic balloon pump (iabp) unit consumes a lot of helium.
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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 during a routine check, the cs300 intra-aortic balloon pump (iabp) unit consumes a lot of helium.There was no patient involvement.
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Manufacturer Narrative
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Additional contact information: event site postal code- (b)(6).It was reported that during routine check, the cs300 intra aortic balloon pump (iabp) consumes a lot of helium.A getinge field service engineer (fse) diagnosed, not finding any helium leak, but if there is a leak in the drive manifold and k6a.Drive manifold (0104-00-0018) drive manifold insulator (0349-00-0301), and vent valve (0119-00-017) were replaced and the equipment was repaired.The equipment is suitable for use.No patient involvement.
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