BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 21191723 · Received January 20, 2025

    Report

    Report Number
    2249723-2025-0000279
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    January 2, 2025
    Report Date
    April 11, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567112541
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINTS ASSOCIATED WITH CONSOLE DAMAGE (COSMETIC DAMAGE TO THE IABP BODY/CART) ARE RELATED TO DAMAGE TO THE CONSOLE BODY OR CART THAT IS COSMETIC IN NATURE. THE FAILURE MODE HAS NOT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY IN THE PAST TWO YEARS AND HAS A REMOTE PROBABILITY OF RESULTING IN A DEATH OR SERIOUS INJURY, AS DOCUMENTED WITHIN THE RISK MANAGEMENT FILE. ADDITIONALLY, THE FAILURE MODE HAS BEEN CONFIRMED THROUGH THE MEDICAL AFFAIRS TEAM TO BE UNLIKELY TO RESULT IN A DEATH OR SERIOUS INJURY. DATASCOPE WILL NO LONGER REPORT FUTURE EVENTS FOR COMPLAINTS ASSOCIATED WITH COSMETIC CONSOLE DAMAGE, UNLESS THE FAILURE MODE IS FOUND TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1 FOR EVENT SITE NAME, THE FULL EVENT SITE NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, E1(EVNT SITE TELEPHONE, EVENT SITE EMAIL), E2, E3, G3, G6, H2, H3, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: D10. ADDITIONAL INITIAL REPORTER: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) ONSITE NUH REPLACED CASTER SUCCESSFULLY AND COMPLETED THE REPAIR. TEST MOVING MACHINE AND LOCK AND RESULT PASSED. PERFORM MACHINE FUNCTIONAL TESTS AND SAFETY TEST PASSED. RETURN TO USER, MACHINE WORKING OK. THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART QTY: 2 WITH A REPORTED UNIT FAILURE OF FAULTY WHEELS. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO HAVE DAMAGED WHEELS WITH THE RUBBER MISSING IN SOME AREAS. PROBABLE ROOT CAUSE IS EXPECTED WEAR AND TEAR.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PRE-USE CHECK OF THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT, THE CASTOR WHEELS ARE WORE OFF. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525720 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-55 10607567112541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown