BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 24868450 · Received April 14, 2026

    Report

    Report Number
    2249723-2026-0002263
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 22, 2026
    Report Date
    April 10, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTERIZATION LIMIT E1 EVENT SITE NAME IS WUHAN HOSPITAL OF INTEGRATED TRADITIONAL CHINESE AND WESTERN MEDICINE; EVENT SITE TELEPHONE NUMBER IS: (B)(6).A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP(IABP) HAD SUDDENLY LOST ITS BACK PULSE DURING USE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939106 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-45 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown