BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABIOMED BVS5000 VAD

    MDR report key: 31488 · Received January 30, 1996

    Report

    Report Number
    31488
    Event Type
    Malfunction
    Date Received
    January 30, 1996
    Report Date
    September 6, 1995
    Manufacturer
    ABIOMED CARDIOVASCULAR, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VAD FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABIOMED BVS5000 VAD VENTRICULAR ASSIST DSQ ABIOMED CARDIOVASCULAR, INC. B950505000

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO