BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILEDIAGNOST WDR

    MDR report key: 3731144 · Received March 18, 2014

    Report

    Report Number
    3731144
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 18, 2014
    Manufacturer
    SEDECAL USA, INC
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN X-RAY TECHNICIAN (TECH) WAS MOVING A PORTABLE X-RAY MACHINE TO A PATIENT'S ROOM IN ORDER TO TAKE X-RAYS. THE MACHINE IS SELF-PROPELLED, AND STOPPED GOING OVER AN EXPANSION JOINT ON THE FLOOR. WHEN THE TECH PULLED THE MACHINE BACKWARDS TO GET IT GOING AGAIN, THE MACHINE KEPT MOVING EVEN THOUGH THE DRIVE MECHANISM WASN'T BEING ENGAGED BY THE TECH. THE MACHINE PUSHED THE TECH INTO AN ADJOINING WALL, CAUSING A BRUISE ON HER HIP. THE MACHINE WAS TAKEN OUT OF SERVICE FOR EVALUATION BY CLINICAL ENGINEERING. THE TECH WAS NOT SERIOUSLY INJURED.MANUFACTURER SENT REPRESENTATIVES IN TO REPAIR THE MACHINE. MANUFACTURER WILL PROVIDE COMPLETED WORK ORDER, BUT NOT WILLING TO DOCUMENT ANYTHING INDICATING FULL REPAIRS ARE COMPLETED, AND UNIT CAN BE RETURNED FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160367 MOBILEDIAGNOST WDR SYSTEM, X-RAY, MOBILE IZL SEDECAL USA, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *