BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 20339872 · Received September 30, 2024

    Report

    Report Number
    2249723-2024-0003983
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 10, 2024
    Report Date
    April 9, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D8, D9, (G1(CONTACT OFFICE, CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) OBSERVED AND WAS ABLE TO REPLICATE THE ERROR. FSE REPLACED MAIN BOARD, SOLENOID DRIVER BOARD, AND MOTOR CONTROL BOARD, DIDN'T RESOLVE THE ISSUE. FOUND BURN MARKS ON THE TEMPERATURE SENSOR HARNESS. REPLACED THERMOSTAT CABLE (D012-00-0893-02) AND ERROR REMAINED. PUMP ASSEMBLY REQUIRES REPLACEMENT. CUSTOMER HAS DECIDED TO NO LONGER REPAIR THE UNIT. THE CUSTOMER HAS DECIDED TO REJECT THE REPAIR AND RETIRE THE UNIT. THE CUSTOMER HAS MOVED ON TO USING NEWER TECHNOLOGY, CARDISOAVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING STARTUP, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS DISPLAYING ELECTRICAL ERROR 50 WEEKEND. MAY NEED A NEW HELIUM TANK AS WELL. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) WAS DISPLAYING ELECTRICAL ERROR 50 WEEKEND. MAY NEED A NEW HELIUM TANK AS WELL. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948966 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown