BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    300 WOUND SURFACE

    MDR report key: 2752296 · Received April 22, 2010

    Report

    Report Number
    1045510-2010-00006
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    March 30, 2010
    Report Date
    March 30, 2010
    Manufacturer
    APEX MEDICAL CORP.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HILL-ROM BECAME AWARE OF AN EVENT WITH ONE OF ITS IMPORTED PRODUCTS, THE 300 WOUND SURFACE ALTERNATING PRESSURE THERAPY MATTRESS, WHERE A NURSE HAD RECEIVED AN ALLEGED SECOND DEGREE BURN TO HER THUMB AND FINGER. THE INCIDENT OCCURRED DURING AN ATTEMPT TO REPLACE THE AIR SUPPLY UNIT (ASU) FROM THE FLOOR BACK ON THE BED FOOTBOARD. THE POWER CORD RECEPTACLE WAS UNKNOWINGLY DISLODGED FROM THE ASU HOUSING EXPOSING THE NURSE TO LIVE INTERNAL COMPONENTS. THE NURSE RECEIVED A SHOCK TO HER THUMB AND FINGER WHEN SHE GRABBED THE POWER CORD OF THE ASU DUE TO HER RING AND THUMB CONTACTING ELECTRIFIED CIRCUITRY. THE NURSE WAS TREATED BY AN EMERGENCY ROOM DOCTOR FOR SECOND DEGREE BURNS TO HER THUMB AND FINGER. HILL-ROM'S TECHNICIAN INSPECTED THE ASU AND CONCLUDED THE POWER CORD RECEPTACLE MAY HAVE BEEN DISLODGED WHEN THE NURSE REMOVED OR REPLACED THE ASU FROM OR TO THE FOOTBOARD. NO OTHER PROBLEMS WERE FOUND WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 300 WOUND SURFACE FNM APEX MEDICAL CORP. 4937 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening