BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RAIOGRAPHIC KRD

    MDR report key: 663811 · Received January 9, 2006

    Report

    Report Number
    MW1037693
    Event Type
    Malfunction
    Date Received
    January 9, 2006
    Date of Event
    January 6, 2006
    Report Date
    January 9, 2006
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    GE KRD RADIOGRAPHIC ROOM. WHEN RELOADING THE BACKUP CALIBRATION SOFTWARE THROUGH THE WORKSTATIONS, IT WILL ONLY ALLOW YOU TO RELOAD ONCE. THE FUNCTION KEY WILL DISAPPEAR. TO RELOAD BACKUP DATA REQUIRES THE OPERATOR TO RELOAD THE ENTIRE WORKSTATION SOFTWARE. THIS WILL CAUSE ALL THE PT DATA AND IMAGES TO BE DELETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL RAIOGRAPHIC KRD GE DIGITAL RAD ROOM KRD IZO GE MEDICAL SYSTEMS KRD *

    Patients

    Seq Age Sex Outcome Treatment
    1 *