BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJI SMART CR

    MDR report key: 1010159 · Received February 19, 2008

    Report

    Report Number
    1010159
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 19, 2008
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    THE CR READER LOCATED IN THE INPATIENT VIEWING AREA WILL PERIODICALLY NOT PROCESS THE IMAGING FOR THE CR PLATE THAT IS BEING PROCESSED. WHEN THIS OCCURS, A CLEAR IMAGE DISPLAYS AND A BROKEN COMMUNICATION ERROR MESSAGE APPEARS WITH A RESET BUTTON. UPON PRESSING THE RESET BUTTON, WHICH HAS TO BE PRESSED IN ORDER TO PROCEED, AN IMAGE DISPLAYS. HOWEVER, THE IMAGE THAT APPEARS IS NOT THE CORRECT IMAGE BELONGING TO THE PATIENT, IT WAS THE PREVIOUSLY PROCESSED IMAGE FROM THE PREVIOUS PATIENT. THIS IS AN INTERMITTENT PROBLEM THAT MAY CAUSE PATIENTS TO RECEIVE UNNECESSARY TREATMENT, OR MAY CAUSE TREATMENT NEEDED TO BE MISSED. THE CR READER WAS PLACE OUT OF SERVICE UNTIL FURTHER TESTING RESOLVES THE ABOVE ISSUES. I WAS ACTUALLY ABLE TO TALK TO THE FUJI REP. THERE HAVE NOT BEEN ANY RECENT SOFTWARE UPGRADES OR UPDATES NOR DO THEY HAVE ANY UPGRADES THAT NEED TO BE INSTALLED. THE REP AND OUR IMAGING SERVICES HAVE IDENTIFIED THE PROBLEM. THERE WAS A DUPLICATE IP ADDRESS WITHIN THE HOSPITAL AND WHEN THERE WAS A CONFLICT, THE CONNECTION WOULD DROP OFF THE NETWORK AND MOMENTARILY LOSE CONNECTION AND THAT IS WHAT CAUSED THE CR TO DISPLAY AN IMAGE FROM THE PREVIOUS PATIENT. IMAGING SERVICES HAS RECEIVED ANOTHER IP ADDRESS AND THE PROBLEM HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJI SMART CR COMPUTED RADIOGRAPHY SYSTEM JAK FUJIFILM MEDICAL SYSTEMS CR-1R346RU *

    Patients

    Seq Age Sex Outcome Treatment
    1 *