BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XRAY MACHINE

    MDR report key: 663676 · Received January 9, 2006

    Report

    Report Number
    MW1037682
    Event Type
    Injury
    Date Received
    January 9, 2006
    Date of Event
    January 6, 2006
    Report Date
    January 9, 2006
    Manufacturer
    GE MEDICALS
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    RELOADING THE BACK UP CALIBRATION DATA ON THE SYSTEM, THE RESTORE KEY WILL DISAPPEAR AFTER THE FIRST TIME. DUE TO THIS MALFUNCTION ALL PT IMAGES AND DATA ARE LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XRAY MACHINE GEXID DIGITAL RADIOGRAPHIC IZO GE MEDICALS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention