BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACARE BED

    MDR report key: 4377186 · Received December 19, 2014

    Report

    Report Number
    1824206-2014-02854
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 20, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    HILL ROM TECHNICIAN FOUND THE UNIT OPERATING AS DESIGNED. CONFIRMED THERE WAS NO MALFUNCTION WITH THE DEVICE. THE REPORTED INJURY IS SERIOUS IN NATURE PER FDA DEFINITION. HOWEVER, THERE WAS NO EVIDENCE OF A MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. DEVELOPMENT OF PRESSURE ULCERS IS MULTIFACTORIAL AND CANNOT BE ONLY ATTRIBUTED TO PERFORMANCE OF THE SURFACE. RISK FACTORS INCLUDE PROTEIN-CALORIE MALNUTRITION, MICROCLIMATE (SKIN WETNESS CAUSED BY SWEATING OR INCONTINENCE), DISEASES THAT REDUCE THE SENSATION IN THE SKIN, SUCH AS PARALYSIS OR NEUROPATHY. POSITION CHANGES ARE KEY TO PRESSURE SORE PREVENTION AND TREATMENT. THESE CHANGES NEED TO BE FREQUENT, REPOSITIONING NEEDS TO AVOID STRESS ON THE SKIN, AND BODY POSITIONS NEED TO MINIMIZE THE RISK OF PRESSURE ON VULNERABLE AREAS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THE MATTRESS WAS NOT INFLATING PROPERLY. THE SEAT SECTION WAS DEFLATED TO THE METAL FRAME AND THE PATIENT WOUNDS ARE WORSENING. THE PATIENT IS CURRENTLY TREATED DAILY WITH DRESSING AND OINTMENTS. WOUND CARE ALSO COMES ONCE A WEEK. THE WOUNDS HAVE GOTTEN SO BAD THE PATIENT HAS PLASTIC SURGERY ON HIS BACKSIDE. THE BED WAS LOCATED IN THE PATIENT'S HOME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837941 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other