BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSAVE IABP

    MDR report key: 21549509 · Received March 7, 2025

    Report

    Report Number
    MW5167399
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    February 26, 2025
    Report Date
    March 2, 2025
    Manufacturer
    GETINGE / DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    JO
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS ADMITTED TO THE CCU AT (B)(6) & WHILE BEING CONNECTED TO THE INTRA AORTIC BALLOON NAMED "CARDIOSAVE" FROM GETINGE, A SUDDEN SHUT DOWN HAPPENED. LATER, WE FIGURED OUT THAT THIS SYSTEM IS ON RECALL, BUT NO PROPER ACTION WAS TAKEN TO INFORM THE HOSPITAL/USERS OF THIS RECALL AND HOW TO TACKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144202 CARDIOSAVE IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP GETINGE / DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Life Threatening