BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 147962 · Received February 5, 1998

    Report

    Report Number
    147962
    Event Type
    Death
    Date Received
    February 5, 1998
    Date of Event
    January 27, 1998
    Report Date
    February 4, 1998
    Manufacturer
    PHYSIO-CONTROL CORP.
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT WHO HAD GONE INTO CARDIAC ARREST, WAS REVIVED WITH THE USE OF A DEFIBRILLATOR. WHILE BEING TRANSPORTED TO ICU, THE PT'S HEARTRATE WAS BEING MONITORED WITH THE DEFIBRILLATOR DEVICE. EN ROUTE, THE DEFIBRILLATOR SHUT ITSELF OFF, THE PT WENT INTO ASYSTOLE, THE PT WAS REVIVED IN ICU, AND THE PT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * DEFIBRILLATOR LDD PHYSIO-CONTROL CORP. LIFEPAK 9 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| L