BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 19258589 · Received May 7, 2024

    Report

    Report Number
    2249723-2024-01867
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 25, 2024
    Report Date
    February 3, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    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 (D1, D2, D3, D4, G4, H4, H5).

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED HELIUM REGULATOR (0103-00-0637) ACCORDING TO MANUFACTURER SPECIFICATIONS. ALL FUNCTIONAL AND SAFETY CHECKS WERE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CHECK AFTER UPGRADING THE SOFTWARE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A PRESSURE REGULATOR HELIUM LEAK. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641827 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

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