BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 24531685 · Received March 6, 2026

    Report

    Report Number
    2249723-2026-0001584
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 6, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. H11: EVENT SITE NAME: (B)(6) HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED BY GGJ ENGINEERS DURING A PRE DELIVERY INSPECTION THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) FAILED THE PIM LEAK TEST AND THE DRIVE MANIFOLD TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591583 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown