BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADULT DEFIBRILLATOR PADS

    MDR report key: 5350352 · Received January 4, 2016

    Report

    Report Number
    MW5058986
    Event Type
    Injury
    Date Received
    January 4, 2016
    Date of Event
    August 8, 2015
    Report Date
    August 12, 2015
    Manufacturer
    MEDTRONIC PLC
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR PADS ON PT. PT SHOCKED ONCE AT 120 JOULES WITHOUT INCIDENT. PATIENT SHOCKED A SECOND TIME AT 200 JOULES AND PADS ARCED AND STARTED ON FIRE. PT, PADS, AND TEGADERM FROM DRESSING CAUGHT ON FIRE WITH VISIBLE FLAMES. FIRE PATTED OUT BY NURSE, PADS REPLACED, CODE CONTINUED. PT EXPIRED, UNABLE TO DETERMINE IF EVENT CONTRIBUTED TO DEATH, AUTOPSY RESULTS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061 ADULT DEFIBRILLATOR PADS MKJ MEDTRONIC PLC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention