BEUDAMED
    FDA Adverse Event Death Summary report: N

    35-X PROFLEXX AMBULANCE COT

    MDR report key: 1603489 · Received February 1, 2010

    Report

    Report Number
    1523574-2010-00001
    Event Type
    Death
    Date Received
    February 1, 2010
    Date of Event
    January 14, 2010
    Report Date
    February 1, 2010
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPRESENTATIVE VISUALLY INSPECTED AND PHOTOGRAPHED STRETCHER AT USER LOCATION. USER REFUSED TO RETURN STRETCHER TO MANUFACTURER.

    Description of Event or Problem · 1

    (B) (6) AMBULANCE WAS EN ROUTE ON A NON-EMERGENCY TRANSPORT OF PATIENT FROM HOSPITAL TO NURSING HOME. AMBULANCE DRIVER VEERED OFF THE ROADWAY INTO A TREE AND UTILITY POLE AT 49 MPH. PATIENT WAS PRONOUNCED DEATH AT THE SCENE OF THIS SINGLE-VEHICLE ACCIDENT. NO SHOULDER RESTRAINT WAS APPLIED TO THE PATIENT CONTRARY TO STRETCHER MANUFACTURER'S RECOMMENDATION. STRETCHER LOWER FRAME WAS DAMAGED AS A RESULT OF THE ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35-X PROFLEXX AMBULANCE COT 35-X PROFLEXX AMBULANCE COT FPO FERNO-WASHINGTON, INC. 35-X NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death