BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FERNO MODEL 35X PROFLEXX AMBULANCE STRETCHER

    MDR report key: 1170332 · Received September 12, 2008

    Report

    Report Number
    1523574-2008-00009
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 12, 2008
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER HAS REQUESTED ACCESS TO THE STRETCHER TO COMPLETE FAILURE ANALYSIS. THE STRETCHER REMAINS IN THE POSSESSION OF THE FACILITY. MANUFACTURER WILL FOLLOW-UP WITH THE FACILITY TO MAKE ARRANGEMENTS FOR FAILURE ANALYSIS OF INCIDENT STRETCHER.

    Description of Event or Problem · 1

    AMBULANCE SERVICE ATTENDANTS WERE TRANSFERRING A PATIENT FROM THE HOSPITAL TO THE AMBULANCE. AMBULANCE STRETCHER LOWERED AT PATIENT'S FOOTEND AND STRUCK THE BACK OF THE ATTENDANT'S RIGHT LEG. ATTENDANT SUFFERED A RIGHT TIBIA FRACTURE. THE FRACTURE DID NOT REQUIRE SURGICAL INTERVENTION. PATIENT WAS NOT INJURED AND REMAINED SECURELY FASTENED TO THE STRETCHER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention