BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35-P PROFLEXX

    MDR report key: 2503218 · Received March 20, 2012

    Report

    Report Number
    1523574-2012-00003
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 11, 2012
    Report Date
    February 19, 2012
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS NINE YEARS OLD. THE SCREW AND BUSHING USED TO ATTACH THE WHEEL TO THE LOAD FRAME WERE RUSTED AND THE LOAD WHEEL HAD THREATS WORN INTO BUSHING HOLE.

    Description of Event or Problem · 1

    WHEN UNLOADING A STRETCHER THE FRONT LOAD WHEEL BOLT AND BUSHING CAME OUT OF THE LOAD WHEEL CAUSING THE WHEEL TO FALL OFF THE LOAD FRAME. THE STRETCHER THEN TIPPED TO ONE SIDE. THE EMT AT THE FOOT END OF THE STRETCHER ASSUMED ALL THE WEIGHT ON THEIR ARM AND BACK. THE EMT WAS TREATED AT A MEDICAL FACILITY AND RELEASED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention