BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISION BLOWER KIT

    MDR report key: 6186387 · Received December 19, 2016

    Report

    Report Number
    1824206-2016-00532
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESSURE WOUND WAS TREATED WITH DAKINS SOLUTION AND ABDOMINAL PADS. 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 BLOWER CONNECTION WAS NOT PROPERLY ATTACHED CAUSING THE BLOWER TO NOT FUNCTION AS DESIGNED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BLOWER IN AUGUST 2016. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BLOWER. THE TECHNICIAN PROPERLY CONNECTED THE BLOWER 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 DEVELOPED A PRESSURE ULCER ON HIS SACRUM THAT PROGRESSED TO STAGE 4. THE BLOWER WAS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837310 ENVISION BLOWER KIT BED FLOTATION THERAPY POWERED IOQ HILL-ROM BATESVILLE P136026

    Patients

    Seq Age Sex Outcome Treatment
    1 Other