BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFE-PAK 8

    MDR report key: 283585 · Received June 26, 2000

    Report

    Report Number
    283585
    Event Type
    Death
    Date Received
    June 26, 2000
    Date of Event
    May 6, 2000
    Report Date
    June 19, 2000
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DIED. IT IS UNCLEAR IF DEATH WAS RELATED IN ANY WAY TO THE DEVICE. IN AN ABUNDANCE OF CAUTION FACILITY IS REPORTING SUCH. PT BROUGHT INTO EMERGENCY DEPARTMENT FOR MULTIPLE STAB WOUNDS OF CHEST. REQUIRED THORACOTOMY. FOUND TO HAVE TEARS IN THE AORTA AND ACTIVE BLEEDING. LARGE AMOUNT OF BLOOD IN CHEST. THE HEART WAS EMPTY. PT BECAME BRADYCARDIC AND OPEN HEART MASSAGE INITIATED. INTRATHORACIC DEFIBRILLATION INITIALLY UNSUCCESSFUL DUE TO FAILURE OF THE INTERNAL PADDLES TO DISCHARGE. ANOTHER DEFIBRILLATOR UTILIZED TO REGAIN COORDINATED SINUS RHYTHM. PT TAKEN TO OR FOR EMERGENT SURGERY AND THEN TO CRITICAL CARE. SEVERAL DAYS POST-OP NEUROLOGICAL EVALUATION DIAGNOSED PT WITH AN ABSENCE OF CORTICAL FUNCTION. ON 5/13 PT DECLARED BRAIN DEAD AND WAS ALLOWED TO EXPIRE. MEDICAL EXAMINER NOTIFIED. PRELIMINARY REPORT: CAUSE OF DEATH DUE TO COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE-PAK 8 CASSETTE DEFIBRILLATOR LDD PHYSIO-CONTROL L-P 8 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death