BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITRON AT*HOME

    MDR report key: 4320561 · Received December 2, 2014

    Report

    Report Number
    1824206-2014-02729
    Event Type
    Injury
    Date Received
    December 2, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 3, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    PMA / PMN Number
    K942184
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS DIAGNOSED WITH A STAGE 4 WOUND ON HIS RIGHT ISCHIUM. THE WOULD WAS TREATED WITH A WOUND VAC. THE PT HAS A PRE-EXISTING STAGE 4 SACRAL WOUND. THE HILL-ROM TECHNICIAN INSPECTED THE BED. HE FOUND THE PLENUM PRESSURE WAS WITHIN NORMAL OPERATING RANGE. HE DID FIND THE AIR INTAKE FILTER WAS CLOGGED. HE INSERVICED THE ACCOUNT ON PROPER MAINTENANCE OF THE BED. THE REPORTED INJURY IS SERIOUS IN NATURE PER FDA DEFINITION. THERE WAS NO EVIDENCE OF A MALFUNCTION. 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 PT'S WIFE REPORTED TO HILL-ROM THAT HER HUSBAND DEVELOPED A BED SORE. THE BED WAS LOCATED IN THE PT'S HOME AT THE TIME OF THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYS AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776156 CLINITRON AT*HOME BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1