BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINITRON AT-HOME

    MDR report key: 2012558 · Received February 28, 2011

    Report

    Report Number
    1045510-2011-00007
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    INX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A SVC CALL OF AN ALLEGED MALFUNCTION OF ONE OF ITS RENTAL CLINITRON AT-HOME AIR FLUIDIZED THERAPY BEDS. THE SVC CALL ALLEGED PROBLEMS WITH BED FLUIDIZATION CAUSING THE SURFACE TO REMAIN STATIC AND ALLEGEDLY CONTRIBUTING TO OPENING UP THE PT'S RECENT FLAP SUTURE. HILL-ROM SVC TECHNICIANS INVESTIGATED THE BED AND DISCOVERED AN ELECTRICAL BOX MALFUNCTION CAUSED FLUIDIZATION TO STOP FUNCTIONING. HILL-ROM SVC TECHNICIANS WERE TOLD BY THE CAREGIVER THAT THE PT WAS TRANSPORTED TO THE HOSPITAL FOR WOUND TREATMENT AND WERE NOT MADE AWARE OF THE ALLEGED FLAP REOPENING. THE SVC TECHNICIANS REPLACED THE ELECTRICAL BOX TO RESTORE FLUIDIZATION FUNCTION TO THE BED PRIOR TO PT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITRON AT-HOME AIR FLUIDIZED THERAPY BED INX HILL-ROM MANUFACTURING, INC. 90006 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other