BEUDAMED
    FDA Adverse Event Death Summary report: N

    AED

    MDR report key: 1102984 · Received August 8, 2008

    Report

    Report Number
    3023750-2008-00189
    Event Type
    Death
    Date Received
    August 8, 2008
    Report Date
    July 11, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K002232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BUT ADDITIONAL TIME IS REQUIRED TO COMPLETE THE INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PT COLLAPSED WHILE USING A TELEPHONE. A PARAMEDIC AMBULANCE CREW ARRIVED AND FOUND THE PT TO BE IN CARDIO-RESPIRATORY ARREST. BASIC LIFE SUPPORT WAS COMMENCED. THE DEVICE WAS TURNED ON AND PLACED INTO MANUAL MODE WHERE THE PARAMEDIC IDENTIFIED A VENTRICULAR FIBRILLATION AND CHOSE TO DELIVER A 200-JOULE SHOCK. THE DEVICE APPEARED TO CHARGE, WITH THE SHOCK BUTTON FLASHING BUT WHEN THE SHOCK BUTTON WAS PRESSED THE DEVICE FAILED TO DELIVER A SHOCK. AT THIS TIME A RAPID RESPONSE CAR PARAMEDIC ARRIVED AT THE SCENE AND THEIR DEVICE WAS UTILIZED IN MANUAL MODE. THIS DEVICE SHOWED THE PT TO BE IN AN ASYSTOLIC RHYTHM. BASIC LIFE SUPPORT WAS CONTINUED ALONG WITH ATTEMPTS BY BOTH PARAMEDICS TO GAIN INTRAVENOUS ACCESS AND SECURE THE PT'S AIRWAY USING INTUBATION. BOTH WERE UNSUCCESSFUL. DESPITE CONTINUED ATTEMPTS, THE PT WAS DECLARED DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED MKJ WELCH ALLYN PROTOCOL, INC. AED20

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death