BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21109342 · Received January 9, 2025

    Report

    Report Number
    2249723-2025-0000134
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 23, 2024
    Report Date
    March 24, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) STATED CUSTOMER REPORTED THE EXTERNAL TANK WAS LEAKING AND HOLDING PRESSURE, A NEW NEEDED TO BE PLACED ON THE UNIT EVERY WEEK. FSE CONFIRMED THE CART DID HAVE A LEAK AND REPLACED THE REGULATOR (0103-00-0637), PRESS XDCR (0682-00-0092-01), TUBING ASSY (0004-00-0103-02) . FSE PERFORMED A FULL CALIBRATION AND TESTED THE UNIT. THE EQUIPMENT WORKS TO THE MANUFACTURER¿S SPECS, IS CLEARED FOR CLINICAL USE, AND WAS RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAVE HELIUM LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169147 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