BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL, MADE FOR: PHILIPS

    MDR report key: 3088109 · Received April 12, 2013

    Report

    Report Number
    9617251-2013-00001
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    January 24, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SEDECAL S.A.
    Product Code
    IZL
    PMA / PMN Number
    K111725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THIS EVENT IS A DISCONNECTED WIRE IN THE MOTION CONTROL ELECTRONICS.

    Description of Event or Problem · 1

    THERE WERE TWO EVENTS RELATED TO THE SAME PROBLEM. THIS IS A MOBILE X-RAY SYSTEM WITH BATTERY/MOTOR ASSISTED MOTION CONTROL. IN THE FIRST EVENT ((B)(6) 2012), THE X-RAY TECHNOLOGIST COMPLETED AN EXPOSURE. HE HELD THE CONTROL HANDLE AND MOVED THE MOBILE X-RAY. THEN HE RELEASED THE CONTROL HANDLE (BRAKE BAR), AND WENT TO PATIENT. AT THE SAME TIME, THE MOBILE X-RAY CONTINUED TO MOVE 2 METERS ON ITS OWN. NO INJURY WAS NOTED. IN THE SECOND EVENT ((B)(6) 2013), A TECHNOLOGIST WAS MOVING THE UNIT FROM ONE LOCATION TO ANOTHER (USING MOTOR ASSIST). WHILE IN AN ELEVATOR, THE TECHNOLOGIST USING THE MOBILE X-RAY UNIT REPORTED THAT IT STARTED TO SPONTANEOUSLY MOVE LEFT AND RIGHT AND THEN TOWARDS HER. SHE RELEASED THE HANDLE BUT THE UNIT CONTINUED MOVING TOWARDS HER AND STRUCK HER IN THE LEG WHICH RESULTED IN A BRUISE. SO INSTEAD OF DECREASING SPEED AFTER THE SWITCH RELEASE, THE UNIT CONTINUED TO MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158345 SEDECAL, MADE FOR: PHILIPS MOBILE X-RAY IZL SEDECAL S.A. MOBILEDIAGNOST WDR

    Patients

    Seq Age Sex Outcome Treatment
    1