BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 3483027 · Received November 4, 2013

    Report

    Report Number
    3483027
    Event Type
    Death
    Date Received
    November 4, 2013
    Date of Event
    October 25, 2013
    Report Date
    November 4, 2013
    Manufacturer
    CARDIO MEDICAL PRODUCTS, INC
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A FEMALE HAD A CARDIAC ARREST. DEFIBRILLATION PADS WERE APPLIED TO THE PATIENT AND ADVANCED CARDIAC LIFE SUPPORT PROTOCOL WAS FOLLOWED. THE PATIENT WAS DEFIBRILLATED 6 TIMES. UPON THE SECOND DEFIBRILLATION SHOCK, THE DEFIBRILLATOR PADS HAD A SPARK AND ARC. THIS WAS A CARDIO MEDICAL PRODUCTS (CMP) ADULT RADIOTRANSPARENT.THE PATIENT WAS ELDERLY AND DESPITE ALL HEROIC EFFORTS, THE PATIENT EXPIRED. WHEN REMOVING THE DEFIBRILLATOR PADS, IT WAS NOTED THAT A PART (COVER) WAS NOT ON THE DEFIBRILLATOR PAD. THIS PART HAD THE INTERNAL WIRES EXPOSED, RESULTING IN THE POSSIBILITY OF THE SPARK. IN ESSENCE, THE BARE METAL WIRE WAS EXPOSED TO SKIN. THE PATIENT DID NOT HAVE AN INTERNAL DEFIBRILLATOR, WAS DRY, AND DID NOT HAVE A MEDICATION PAD ON THEIR SKIN. ALL PRECAUTIONS WERE MAINTAINED.====================== MANUFACTURER RESPONSE FOR DEFIBRILLATION/CARDIOVERSION ELECTRODES, CARDIO MEDICAL PRODUCTS (PER SITE REPORTER).====================== MANUFACTURER WAS MADE AWARE OF THE ISSUE, BUT THERE HAS BEEN NO RESPONSE PRIOR TO SUBMITTING THIS MEDSUN REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567274 * DEFIBRILLATOR LDD CARDIO MEDICAL PRODUCTS, INC * Y032213-02

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death