BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V

    MDR report key: 21239352 · Received January 27, 2025

    Report

    Report Number
    2249723-2025-0000345
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 7, 2025
    Report Date
    May 5, 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

    UPDATED FIELDS: B4, G3, G6, H2, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED OF VIDEO COLOR PCB (0670-00-0736) AND FLAT CABLE (0012-00-1429) WITH DIAGNOSTIC AND FUNCTIONAL TESTS. REPAIR COMPLETED. FUNCTIONAL TESTS PERFORMED WITH POSITIVE OUTCOME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER START UP THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) DARK DISPLAY AT POWER-UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507490 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.