BEUDAMED
    FDA Adverse Event Other Summary report: N

    INNERVIEWGI

    MDR report key: 455388 · Received April 18, 2003

    Report

    Report Number
    1933477-2003-00003
    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
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "DOUBLE PATIENTS IN A REPORT," THE REPORT PAGE FROM VITRES 3.1 (CONFIRMED BY THE GUI), HAD ONE PATIENT'S IMAGE WITH A SECOND PATIENT'S NAME IN THE HEADER. THEY CONFIRMED THE SITE HAD USED THE SAME PATIENT 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 IF THE SAME PATIENT ID IS USED, THE REPORT DOSES NOT REFRESH, 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 PATIENT 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 CAME FROM THE SERIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNERVIEWGI 3D RADIOLOGY VIEWER SOFTWARE LNX VITAL IMAGES, INC. VPMC-7370E *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other