BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITRON AT*HOME

    MDR report key: 6158106 · Received December 9, 2016

    Report

    Report Number
    1824206-2016-00524
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    IOQ
    PMA / PMN Number
    K942184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXISTING PRESSURE ULCER PROGRESSED TO A STAGE 4, THE MOTHER WAS UNSURE OF THE PRIOR STAGE, ON ONE BUTTOCK. THE PATIENT RECEIVES WOUND CARE TWICE PER MONTH, WITH HIS PARENTS PROVIDING CONTINUAL IN-HOME CARE. THE WOUNDS ARE BEING TREATED WITH ALGINATE BANDAGES AND THE PATIENT IS ALSO TAKING ORAL ANTIBIOTICS FOR THE WOUND'S INFECTION. 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. THE HILL-ROM TECHNICIAN FOUND THE BLOWER AND ELECTRICAL BOX NEEDED TO BE REPLACED. THE TECHNICIAN REPLACED THE BLOWER AND ELECTRICAL BOX TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. PER THE HILL-ROM USER MANUAL, POOR FLUIDIZATION; IF FLUIDIZATION IS SLUGGISH OR UNEVEN, NOTIFY YOUR HILL-ROM REPRESENTATIVE. FLUIDIZATION IS AFFECTED BY THE FOLLOWING: ROOM TEMPERATURE, HUMIDITY, THE AMOUNT OF MATERIALS, SUCH AS FLUID, CELLS OR CELLULAR DEBRIS, WHICH HAS ESCAPED FROM THE BLOOD VESSELS AND HAS BEEN DEPOSITED IN TISSUES OR ON TISSUE SURFACES, RESTRICTED AIR CIRCULATION FROM BLANKETS ON THE BED. IT IS UNKNOWN IF THE ACCOUNT PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT ALLEGING THE PATIENTS WOUNDS HAVE GOTTEN WORSE. THE BED WAS LOCATED AT THE PATIENTS 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
    811188 CLINITRON AT*HOME BED, AIR FLUIDIZED IOQ HILL-ROM BATESVILLE P0800010016

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR