BEUDAMED
    FDA Adverse Event Summary report: N

    FUJI FCR XG5000

    MDR report key: 1341457 · Received March 4, 2009

    Report

    Report Number
    1341457
    Date Received
    March 4, 2009
    Date of Event
    February 2, 2009
    Report Date
    March 4, 2009
    Manufacturer
    FUJIFILM MEDICAL SYSTEM, USA, INC.
    Product Code
    IXW
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE TECH WAS DEVELOPING AN X-RAY IMAGE IN THE FUJI CR READER, HE NOTICED PRIOR TO SENDING TO PACS, THAT IMAGES WERE INCORRECT. THEY "JUMPED INTO ANOTHER PATIENT'S JACKET". A SERVICE CALL WAS PLACED AND FUJI SERVICE ENGINEER CAME IN. LOGS WERE SENT TO JAPAN FOR REVIEW. A SIMILAR EVENT OCCURRED APPROXIMATELY A YEAR AGO. THE HOSPITAL BELIEVES THAT THIS PROBLEM MAY BE TRIGGERED WHEN A JAM OF A CR CASSETTE OCCURS, AND THE CR READER IS RE-BOOTED TO CLEAR THE JAM. UNDER THESE CIRCUMSTANCES IT APPEARS THAT THE CR IMAGE MAY BE STORED IN THE PROPER (NEW) PATIENT'S FOLDER, AS WELL AS IN THE PREVIOUS PATIENT'S FOLDER (BEARING THE ACCESSION NUMBER OF THE NEW PATIENT). FUJI IDENTIFIED THE CAUSE OF THE ISSUE AND HAS INSTALLED A SOFTWARE UPGRADE VERSION 2.5 IN THE CR READER, WHICH THEY HAVE STATED WILL PREVENT A REPEAT OCCURRENCE OF THIS PROBLEM. THE HOSPITAL HAS 13 OF THESE CR READERS AND IS IN THE PROCESS OF HAVING THE UPGRADE INSTALLED IN THE OTHER READERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJI FCR XG5000 COMPUTED RADIOGRAPHY PLATE READER IXW FUJIFILM MEDICAL SYSTEM, USA, INC. FCR XG5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR