BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 2761092 · Received September 5, 2012

    Report

    Report Number
    2761092
    Event Type
    Death
    Date Received
    September 5, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 4, 2012
    Manufacturer
    JARVIK HEART, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UP TO BATHROOM WITH ASSIST OF 1. PATIENT COMPLAINED OF WEAKNESS, ASSISTED TO FLOOR AND CALLED FOR HELP. PATIENT BECAME UNRESPONSIVE AND CODE CALLED. PATIENT IN V. FIB. DURING CODE, IT WAS NOTED THE POWER SUPPLY TO HIS LVAD WAS NOT CONNECTED TO THE CONTROLLER, NO ALARMS SOUNDED. POWER RECONNECTED, PULSE RE-ESTABLISHED. PATIENT DID NOT WAKE UP. TRANSFERRED INTUBATED WITH PULSE TO CCU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * VENTRICULAR ASSIST, BYPASS DSQ JARVIK HEART, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death