BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V

    MDR report key: 19417525 · Received May 29, 2024

    Report

    Report Number
    2249723-2024-02199
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 16, 2024
    Report Date
    February 13, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567112619
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THE DISPLAY WAS COMPLETELY WHITE WHEN TURNED ON. THE FSE REPLACED THE PCB COLOR VIDEO CABLE (D670-00-0736) AND DISPLAY TO VIDEO PCB (D012-00-1429) WERE REPLACED. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE MORNING AFTER START UP, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT WENT COMPLETELY WHITE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660355 CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3023-67 10607567112619

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.