BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IIP

    MDR report key: 1419194 · Received July 17, 2009

    Report

    Report Number
    1419194
    Event Type
    Malfunction
    Date Received
    July 17, 2009
    Date of Event
    June 13, 2009
    Report Date
    June 24, 2009
    Manufacturer
    FUJIFILM MEDICAL SYSTEM USA, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DELAY IN TREATMENT RELATED TO EQUIPMENT FAILURE ON 4 PATIENTS. THE IMAGES WERE FROZEN ON THE LIST AND WOULD NOT TRANSMIT ON THE FUJI READER EQUIPMENT. THE SYSTEM WAS REBOOTED WITHOUT CHANGE. A FEW HOURS LATER THE SYSTEM WAS AGAIN SHUT DOWN AND REBOOTED AND THE IMAGES THEN DID TRANSFER. IMAGES WERE REPEATED ON EQUIPMENT IN ANOTHER DEPARTMENT. THE NEXT DAY THE SAME ISSUE OCCURRED WITH 4 MORE PATIENTS AND THE SYSTEM WAS SHUT DOWN TO AWAIT EVALUATION BY THE MANUFACTURER. THIS PROBLEM WAS TRACED TO A COMPUTER VIRUS (CONFICKER) WHICH WAS FOUND TO BE AFFECTING 6 FUJI CR UNITS. THE HOSPITAL'S IMAGING SERVICE ENGINEER APPLIED A MICROSOFT PATCH (MS08-067) TO THE 6 FUJI UNITS TO PREVENT THE VIRUS FROM RE-INFECTING THE SYSTEMS.SUBSEQUENT TO THIS PROBLEM ONE OF THE FUJI UNITS EXPERIENCED A SHUTDOWN, WHICH WAS REPAIRED BY REPLACEMENT OF A DEFECTIVE POWER SUPPLY. THIS FAILURE IS NOT THOUGHT TO BE RELATED TO THE VIRUS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IIP COMPUTED RADIOGRAPHY READER AND WORKSTATION LLZ FUJIFILM MEDICAL SYSTEM USA, INC. IIP *

    Patients

    Seq Age Sex Outcome Treatment
    1 *