BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART

    MDR report key: 976511 · Received November 27, 2007

    Report

    Report Number
    976511
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    October 9, 2007
    Report Date
    November 27, 2007
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    FLUID WAS LEAKING FROM THE HOUSING OF THE TANDEM HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART VENTRICULAR ASSIST DEVICE DSQ CARDIAC ASSIST, INC. EC-1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR CARDIAC DRUGS| CARDIAC DRUGS