BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITRON RITEHITE C-8 ASSY

    MDR report key: 5067436 · Received September 10, 2015

    Report

    Report Number
    1824206-2015-00881
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    IOQ
    PMA / PMN Number
    PK964223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN REMOVED THE BED AND HAS TAKEN IT BACK TO THE SERVICE CENTER FOR EVALUATION. THE ACCOUNT STATED THAT THEY DID NOT PROVIDE ANY ADDITIONAL TREATMENT FOR THE PATIENT FOR THESE WOUND OTHER THAN PLACEMENT ONTO THE CLINITRON BED. 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. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE PATIENT DEVELOPED A NEW UNSTAGABLE WOUND ON HIS SACRUM AND RIGHT BUTTOCKS WITH FOUR SMALLER SORES AROUND THOSE TWO AREAS. THE BED WAS LOCATED IN ROOM 402 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
    598769 CLINITRON RITEHITE C-8 ASSY BED, AIR FLUIDIZED IOQ HILL-ROM BATESVILLE P0800010019

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other