BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSACARE BED

    MDR report key: 3807952 · Received May 7, 2014

    Report

    Report Number
    1824206-2014-01411
    Event Type
    Other
    Date Received
    May 7, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT REQUESTED HILL-ROM TO EVALUATE THE BED TO MAKE SURE IT IS FUNCTIONING PROPERLY. THE SERVICE TECHNICIAN INVESTIGATION INDICATED THAT THERE WAS NO EVIDENCE OF A MALFUNCTION HE FOUND THE BED FUNCTIONED AS DESIGNED. MARGARET PETERSON, THE PATIENT'S WIFE, STATED (B)(6) IS (B)(6) TALL AND HIS FEET HUNG OFF OF THEIR OLD BED. THEY PURCHASED THE VERSACARE BED SO IT CAN ACCOMMODATE HOW TALL THE PATIENT IS. BECAUSE OF THIS, SHE STATED SHE DID NOT WATCH THE CONDITION OF HIS WHOLE BODY AS CLOSELY AS SHE SHOULD HAVE. SHE STATED THAT (B)(6) HAD FLAP SURGERY 3 YEARS AGO ON HIS LEFT ISCHIUM AND SINCE THEN HE LAYS PREDOMINANTLY ON HIS RIGHT SIDE. AS A RESULT, THE WAY HIS LEGS COME TOGETHER, THIS PUTS MORE PRESSURE ON THE LEFT HEEL. SHE STATED THAT A DOCTOR CAME TO THE HOME TO TREAT THE WOUND. HE DEBRIDED THE WOUND AND INSTRUCTED HER ON HOW TO PROPERLY MONITOR AND TREAT THE WOUND. AT THE TIME THE DOCTOR WAS THERE, THE WOUND MEASURED AT 3.5 CM DIAMETER WITH AN ESCHAR MEASURING 2.5 CM AND NECROTIC TISSUE AROUND THE EDGE. SINCE THEN, SHE STATED THE WOUND IS HEALING AND LOOKING BETTER. IT HAS PINK SKIN AROUND THE EDGES AND BLEEDS FREELY WHEN SHE CLEANS IT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED IS NOT INFLATING PROPERLY. THE BED IS LOCATED IN THE PATIENT'S HOME. THE ACCOUNT STATED THE PATIENT IS DEVELOPING BED SORES ON THE LEFT HEEL. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT NUMBER (B)(4). THE REPORTED INJURY IS SERIOUS IN NATURE PER FDA DEFINITION; HOWEVER, THERE WAS NO EVIDENCE OF A MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. THE PRESSURE ULCER WAS RELATED TO THE PATIENT'S UNDERLYING CONDITION. 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 BLOOD FLOW TO THE SKIN, SUCH AS ARTERIOSCLEROSIS, OR 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. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275023 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R