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
Electrical /Electronic Property Problem (1198); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2023 |
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 preventative maintenance by getinge field service engineer, the cs300 intra-aortic balloon pump (iabp) unit's electrical test failure 50 in logs verified saline intrusion on main board.There was no patient involvement.
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Event Description
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N/a.
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Manufacturer Narrative
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In order to fix the issue, the fse replaced the main board pcb.Also, as a precaution, the fse replaced the dss datasette and the iab datasette.The fse then performed a complete pm with full calibration, functional testing and safety check to factory specifications.The unit passed all functional and safety checks and was then ready for patient use.
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Search Alerts/Recalls
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