BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFCO

    MDR report key: 1693388 · Received May 10, 2010

    Report

    Report Number
    1693388
    Event Type
    Malfunction
    Date Received
    May 10, 2010
    Date of Event
    April 21, 2010
    Report Date
    May 10, 2010
    Manufacturer
    GF HEALTH PRODUCTS
    Product Code
    ILY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    AN INFANT IN THE NICU HAD AN EXCORIATED BOTTOM. A NURSE USED A "GOOSE NECK" HEAT LAMP TO DRY THE EXPOSED BOTTOM. WHEN THE RN TURNED ON THE LAMP, IT WAS NOT WORKING AND FACILITIES WAS CALLED TO CHANGE THE BULB. AFTER THE LAMP WAS TURNED BACK ON, A POPPING NOISE WAS HEARD AND A SPARK FLEW ON TO THE INFANT'S DIAPER AND IGNITED. THE RN IMMEDIATELY PICKED UP THE INFANT AND REMOVED THE DIAPER TO EXTINGUISH THE FIRE. ANOTHER RN SHUT OFF THE OXYGEN SOURCE. THE INFANT HAS A SMALL BURN ON THE RIGHT GREAT TOE THAT IS BEING TREATED WITH SILVADENE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================CAUSED SMALL BURN ON TOE. HAD POTENTIAL TO CAUSE SERIOUS BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFCO EXAM LAMP, GOOSENECK ILY GF HEALTH PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO NO OTHER THERAPIES