BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK 12

    MDR report key: 2589603 · Received May 19, 2012

    Report

    Report Number
    2589603
    Event Type
    Injury
    Date Received
    May 19, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 8, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS GETTING CARDIOVERTED ONE (1) TIME AND SOME OF HIS CHEST HAIRS CAUGHT ON FIRE. AN ARC APPEARED FROM THE PAD AND AS SOON AS THE FIRE WAS SEEN IT WAS PUT OUT BY THE DOCTOR. PATIENT WAS ASLEEP. FIRST DEGREE INJURY TO THE PATIENT'S UPPER CHEST. SOME HAIRS BURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC LIFEPAK 12 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention