BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFIBRILLATION ELECTRODES

    MDR report key: 3883989 · Received June 11, 2014

    Report

    Report Number
    3009249335-2014-00008
    Event Type
    Death
    Date Received
    June 11, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K082090
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARDIAC SCIENCE HAS CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ABOUT THE INCIDENT. NO INFORMATION HAS BEEN PROVIDED DESCRIBING WHAT THE BIO-MED DID TO CONCLUDE THE PADS WEREN'T WORKING. AN INVESTIGATION OF THE PADS USED DURING THE RESCUE CAN'T BE PERFORMED BECAUSE THEY WERE DISCARDED. PADS ARE SINGLE USE DEVICES AND THE GEL CAN DRY OUT OR THEY CAN BE DAMAGED AFTER USE SO THAT IF THEY ARE CONNECTED TO AN AED FOLLOWING A RESCUE, THE AED MAY INDICATE THAT THE PADS NEED TO BE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER NOTIFIED CARDIAC SCIENCE HE HAD FILED MEDWATCH REPORT (B)(4). "AED USED ON PATIENT, AED CONTINUOUSLY REPEATING TO CHECK PADS. BIO-MED CAME TO CLINIC TO CHECK THE AED, AED FUNCTIONING, PADS WERE NOT WORKING. BIO-MED THREW THE PADS AWAY BEFORE CONTACTING CLINIC MANAGER OR OUR BIO-MED TEAM." THE CUSTOMER REPORTED THE OUTCOME OF THE ADVERSE EVENT AS DEATH; HOWEVER, BASED UPON THE MEDWATCH REPORT THE PATIENT'S DEATH OCCURRED 6 DAYS AFTER THE DATE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345796 DEFIBRILLATION ELECTRODES EXTERNAL DEFIBRILLATION ELECTRODES MKJ CARDIAC SCIENCE CORPORATION 9131 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death