BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITRON AT HOME

    MDR report key: 4202285 · Received October 16, 2014

    Report

    Report Number
    1824206-2014-02484
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 21, 2014
    Product Code
    INX
    PMA / PMN Number
    K942184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECH FOUND THE ZONE 3 PROPORTIONAL VALVE WAS WORN. THE TECH REPLACED THE PROPORTIONAL VALVE TO RESOLVE THE ISSUE. NO ADD'L TREATMENT WAS NEEDED. PT CONTINUED WITH CURRENTLY THERAPY. 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.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT THAT THE BED WAS ALARMING AND THE PT'S PRE-EXISTING PRESSURE SORE IS GETTING WORSE. THE PT STATED THE WOUND ON HER COCCYX HAS DEEPENED TO EXPOSE HER SPINAL BONE. THE BED WAS LOCATED IN THE PT'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
    658030 CLINITRON AT HOME NONE INX 0800

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other