BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITRON AT*HOME

    MDR report key: 5114255 · Received September 30, 2015

    Report

    Report Number
    1824206-2015-00924
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    IOQ
    PMA / PMN Number
    PK942184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE DIFFUSER BOARD AND SIEVE SCREEN WERE WORN. THE WOUND WAS PRE EXISTING BUT DID PROGRESS TO A STAGE 4. THE PATIENT WAS IN THE HOSPITAL FOR 13 DAYS WHERE THE WOUND WAS DEBRIDED. 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. PATIENT WAS REMOVED FROM THE BED AFTER IT WAS NOTED THAT THE BED WAS NOT FLUIDIZING PROPERLY. THE TECHNICIAN REPLACED THE DIFFUSER BOARD AND SIEVE SCREEN TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE PATIENT HAD PRE EXISTING STAGE 2 WOUNDS THAT DEVELOPED INTO STAGE 4 WOUNDS ON HIS RIGHT HIP . THE BED WAS LOCATED AT THE PATIENTS HOME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645955 CLINITRON AT*HOME BED, AIR FLUIDIZED IOQ HILL-ROM BATESVILLE P0800010016

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other