BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISUALPACS

    MDR report key: 500909 · Received December 5, 2003

    Report

    Report Number
    2135350-2003-00004
    Event Type
    Other
    Date Received
    December 5, 2003
    Date of Event
    November 8, 2003
    Report Date
    December 5, 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, PROACTIVE MONITORING OF THE SYSTEM AT A CUSTOMER SITE, IT WAS FOUND THAT PRESENTATION STATES AND KEY IMAGE OBJECTS WERE BEING DELETED BY THE WATERMARK SERVER PRIOR TO BEING COMMITTED TO THE DATABASE. THE ORIGINAL IMAGES ARE NOT DELETED OR ALTERED IN ANY WAY AND STILL EXIST ON THE ARCHIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other