BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3962875 · Received July 7, 2014

    Report

    Report Number
    3962875
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 7, 2014
    Manufacturer
    GE HEALTHCARE
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PT WAS STANDING FOR UPRIGHT X-RAY. THE TECHNOLOGIST TOOK IMAGE BUT CONTROL PANEL MADE AN UNUSUAL SOUND DISPLAYING A VERY RAPID EXPOSURE. TECHICIAN PROCESSED IMAGE, BUT NO IMAGE SHOWED (MEANING EQUIPMENT FAILURE). TECHNICIAN REPOSITIONED PATIENT AND TOOK ANOTHER X-RAY. THE CONTROL PANEL MADE THE SAME UNUSUAL SOUND AND DISPLAYED A VERY RAPID EXPOSURE. THE IMAGE WAS PROCESSED, BUT AGAIN, THERE WAS NO IMAGE. THE PATIENT WAS TAKEN TO ANOTHER X-RAY ROOM TO FINISH THE EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394916 * SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR NO OTHER DEVICES WERE BEING USED ON THE PATIENT AT| NO OTHER THERAPIES| THE TIME OF THE EVENT.