BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATIONAL IMAGING SOFTWARE

    MDR report key: 477191 · Received August 7, 2003

    Report

    Report Number
    2029102-2003-00018
    Event Type
    Malfunction
    Date Received
    August 7, 2003
    Date of Event
    July 8, 2003
    Report Date
    July 8, 2003
    Manufacturer
    CANON U.S.A., INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE HEALTH CARE PROFESSIONAL SELECTED THE REPORT ICON ON THE DISPLAY TO SHOW A PT EXAM REPORT, ANOTHER PT'S EXAM REPORT PRESENTED ON THE SCREEN. THE SYSTEM ADMINISTRATOR WAS ABLE TO REPLICATE THE PROBLEM USING EXAM REPORTS FOR MULTIPLE PTS. THERE WERE NO REPORTS OF PT INJURIES RELATED TO THIS REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RATIONAL IMAGING SOFTWARE PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM LLZ CANON U.S.A., INC. RMR 2U AXL-C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA