BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITRON AT HOME

    MDR report key: 4320444 · Received November 26, 2014

    Report

    Report Number
    1824206-2014-02720
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    October 31, 2014
    Report Date
    October 31, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    PMA / PMN Number
    K942184
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BLOWER WAS INOPERATIVE. THE TECHNICIAN REPLACED THE BLOWER AND THE ISSUE WAS RESOLVED. THE REPORTED INJURY IS SERIOUS IN NATURE PER FDA DEFINITION. HOWEVER, THE DETERIORATION OF THE PRESSURE ULCER TOOK PLACE WHILE THE PATIENT WAS NOT ON A HILL-ROM SURFACE. 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

    THE PATIENT'S WIFE REPORTED THAT HER HUSBAND'S WOUNDS WERE GETTING WORSE AND HE DEVELOPED A NEW WOUND. THE PATIENT IS A DOUBLE AMPUTEE AT THE PELVIS. THE ACCOUNT STATED THAT THE BED ALARMED AND SHUT DOWN AND THEN THEY CONTACTED HILL-ROM. THE TECHNICIAN EVALUATED THE UNIT AND FOUND THE PART NEEDED WAS NOT IN STOCK AND LET THE ACCOUNT KNOW. THE ACCOUNT THEN PLACED THE PATIENT ON A NON-HILL-ROM MATTRESS FOR 7 DAYS, UNTIL THE REPAIR COULD BE COMPLETED. THE ACCOUNT TREATED THE WOUNDS WITH SILVADENE AND TWO TYPES OF ANTIBIOTICS. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769196 CLINITRON AT HOME BED, AIR-FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR