BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21966815 · Received May 6, 2025

    Report

    Report Number
    2249723-2025-0002101
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    October 24, 2024
    Report Date
    May 6, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN BLOCK E1 EVENT SITE NAME: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND CONFIRMED THE REPORTED ISSUE. FSE RESOLVED THE ISSUE INSTALLING A BUSHING REGULATOR HOUSING (D358-00-0069), HIGH PRESSURE HELIUM REGULATOR (D103-00-0637), PRESS XDCR HI PRESSURE (D682-00-0092-01) AND O-RING (D354-00-0209). COMPLETED WITH FULL CALIBRATION, FUNCTIONAL TESTING AND SAFETY CHECK TO FACTORY SPECIFICATIONS. RETURNED TO THE CUSTOMER AND CLEARED FOR CUSTOMER USE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A ROUTINE CHECK THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HELIUM KNOB HAD COME OFF. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102495 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

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