BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOAMBULATOR

    MDR report key: 952152 · Received October 22, 2007

    Report

    Report Number
    952152
    Event Type
    Injury
    Date Received
    October 22, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 19, 2007
    Manufacturer
    HEALTHSOUTH ENGINEERING
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2007, 02:56 PM, PATIENT FITTED INTO AUTOAMBULATOR HARNESS. RAISED UP OUT OF WHEELCHAIR AND ROBOTICS ADJUSTED PROPERLY. GAIT CYCLE INITIATED. PRIOR TO COMPLETION OF ONE CYCLICAL ROTATION AND PRIOR TO INITIATION OF WEIGHT BEARING PATIENT C/O PAIN IN RIGHT HIP. AUDIBLE POPPING SOUND. THERAPIST RETURNED PATIENT TO UNIT. TRANSFER TO ACUTE AND DIAGNOSED WITH HIP FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOAMBULATOR PHYSICAL MEDICINE PRODUCTS FSA HEALTHSOUTH ENGINEERING 01

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R