BEUDAMED
    FDA Adverse Event Injury Summary report: N

    300 WOUND SURFACE

    MDR report key: 2706278 · Received August 14, 2012

    Report

    Report Number
    1045510-2012-00016
    Event Type
    Injury
    Date Received
    August 14, 2012
    Date of Event
    July 24, 2012
    Report Date
    July 24, 2012
    Manufacturer
    APEX MEDICAL CORP
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM BECAME AWARE THAT A PT ALLEGEDLY FELL AND FRACTURED THEIR NOSE DURING USE OF ONE OF ITS SOLD 300 WOUND SURFACE DEVICES. A HILL-ROM SERVICE TECHNICIAN WAS DISPATCHED TO INVESTIGATE THE PT FALL OFF THE DEVICE. WHEN THE TECHNICIAN ARRIVED, STAFF EXPLAINED THE PT FELL, FRACTURED HER NOSE AND INDICATED THE ALTERNATING PRESSURE FEATURE SEEMED TO SHIFT HER TO THE LEFT OR RIGHT ON THE MATTRESS SURFACE. THE SIDE RAILS ON THE UNNAMED BEDFRAME THE DEVICE WAS ON WERE IN THE STOWED DOWN POSITION. STAFF INDICATED THE SIDE RAILS ARE USED DURING BED MOVES AND WERE STOWED AT OTHER TIMES TO REDUCE THE RISKS OF ENTRAPMENT. THE FALL ALLEGEDLY OCCURRED WHEN THE PT ROLLED TO MATTRESS LEFT EDGE WHERE SHE THEN FELL OUT OF BED WHILE THE DEVICE WAS IN ALTERNATING THERAPY MODE. THE TECHNICIAN INSPECTED THE 300 WOUND SURFACE DEVICE AND FOUND IT FUNCTIONING PROPERLY. THE DEVICE HAD BEEN IN THE ACCOUNT FOR 4 YEARS WITHOUT INCIDENT BUT STAFF DISCONTINUED TO USE UNDER THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 300 WOUND SURFACE MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM APEX MEDICAL CORP 4937

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other