BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITREA 2

    MDR report key: 455386 · Received April 18, 2003

    Report

    Report Number
    1933477-2003-00004
    Event Type
    Other
    Date Received
    April 18, 2003
    Date of Event
    March 21, 2003
    Report Date
    March 21, 2003
    Manufacturer
    VITAL IMAGES, INC.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SITE EXPERIENCED, "DOUBLE PATIENTS IN A REPORT." THE REPORT PAGE FROM VITREA 3.1 HAD ONE PATIENT'S IMAGES WITH A SECOND PATIENT'S NAME IN THE HEADER. THEY CONFIRMED THE SITE HAD USED THE SAME PATIENT'S ID (SINUS) FOR BOTH PATIENTS. AFTER ASCERTAINING THE DETAILS, IT WAS DETERMINED THAT THE REPORT FOR VITREA 3.1 AND 3.2 LOOKS AT THE PATIENT ID ONLY, AND THE DATA FROM THE FIRST PATIENT ID IS CARRIED OVER AND PLACED ON THE SCANNED RESULTS OF ALL OF THE PATIENTS SCANNED WITH THE SAME ID. FURTHER TESTING CONFIRMED THAT THE SLIDE TRAY OPERATES AS DESIGNED, BUT THAT THE HEADER DISPLAYS THE INFORMATION FOR THE FIRST LOADED PATIENTS, RATHER THAN THE LAST LOADED PATIENT. THE CURRENT USING VITREA 3.2 MANUAL STATES, "IF YOU INCLUDE IMAGES FOR MORE THAN ONE SERIES FOR THE SAME PATIENT, IN A REPORT, THE REPORT HEADINGS, IF ANY, WILL IDENTIFY THE SERIES YOU LOADED MOST RECENTLY. IT MAY BE IMPORTANT TO IDENTIFY WHICH IMAGES COME FROM THE SERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITREA 2 3D RADIOLOGY VIEWER SOFTWARE LNX VITAL IMAGES, INC. VPMC-7299K *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other