BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITRON RITEHITE

    MDR report key: 3802977 · Received May 5, 2014

    Report

    Report Number
    1824206-2014-01407
    Event Type
    Other
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT STATED THE BED DID NOT ALARM SO THERE WAS NO CAUSE TO CALL HILL-ROM TO REPAIR THE BED. A STAFF MEMBER GOT INTO THE BED TO TEST IT OUT SINCE THE PT WAS STILL COMPLAINING ABOUT PAIN AND FOUND THAT THE BED WAS BOTTOMING OUT. THE TECH INVESTIGATED AND FOUND THE AIR COUPLING WAS LOOSE. THE TECH TIGHTENED THE AIR COUPLING TO RESOLVE THE ISSUE. THE PT HAS A HISTORY OF SQUAMOUS CELL CARCINOMA. ADMITTED TO THE SICU (B)(6) 2014 POST TOTAL LARYNGECTOMY. HE HAD SURGICAL WASH OUT OF ESOPHAGEAL FISTULAS AND PECTORAL FLAP ON (B)(6) 2014. PT WAS ON VASOPRESSORS AND VERY ILL. DURING THIS TIME HE DEVELOPED A DIVERTICULUM AND HAD A COLECTOMY. POOR NUTRITIONAL STATUS AS A RESULT OF THESE MULTIPLE SURGICAL PROCEDURES. ON (B)(6) 2014 PT WAS NOTED TO HAVE A STAGE 1 DECUBITUS ON HIS BACKSIDE. ON (B)(6) 2014, DECUBITUS WAS CONSIDERED TO HAVE PROGRESSED TO A DEEP TISSUE WOUND. ON (B)(6) 2014, PT PLACED ON A CLINITRON BED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED WAS HARD. THE BED WAS LOCATED IN ROOM (B)(6) AT THE ACCOUNT. THE ACCOUNT STATED THE PT WAS COMPLAINING OF THEIR BUTTONS HURTING. THE NURSING STAFF THOUGHT THAT THE PAIN WAS DUE TO PT'S DECUBITUS. PT WAS 1ST ADMITTED WITH A STATE 1 DECUBITUS AND NOW HAS UNSTAGEABLE DECUBITUS. (B)(4). THE REPORTED INJURY IS SERIOUS IN NATURE PER FDA DEFINITION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268109 CLINITRON RITEHITE BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other