BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISUALPACS

    MDR report key: 473904 · Received July 22, 2003

    Report

    Report Number
    2135350-2003-00001
    Event Type
    Other
    Date Received
    July 22, 2003
    Date of Event
    June 23, 2003
    Report Date
    July 22, 2003
    Manufacturer
    EMAGEON UV, INC.
    Product Code
    LLZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE, PRO-ACTIVE MONITORING OF THE SYSTEM AT A CUSTOMER SITE, IT WAS FOUND THAT A NUMBER OF IMAGES WERE BEING SENT TO THE EXCEPTION LOGS. UPON FURTHER INSPECTION, IT WAS FOUND THAT THERE WERE OVER 2,500 IMAGES IN THE EXCEPTION QUE. ALL OF THE IMAGES ARE IMAGES WITH AN IMPLICIT LENGTH SEQUENCE. THE IMAGES STILL RESIDE ON THE ARCHIVE AND CAN BE ACCESSED BY OTHER MEANS, JUST NOT THROUGH THE VISUALPACS VIEWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISUALPACS MEDICAL IMAGE MANAGEMENT DEVICE LLZ EMAGEON UV, INC. 2.2.1G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other