BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANTAGE

    MDR report key: 237890 · Received August 27, 1999

    Report

    Report Number
    2916556-1999-00179
    Event Type
    Malfunction
    Date Received
    August 27, 1999
    Date of Event
    April 8, 1999
    Report Date
    April 8, 1999
    Manufacturer
    ADAC LABORATORIES
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MCD SINGLES COUNT RATE IS NOT DOCUMENTED IN THE MCD USERS MANUAL. CURRENTLY, ADAC SUGGESTS TO THE CUSTOMER TO KEEP THE SINGLES COUNT RATE BETWEEN 800-1600KCPS. IT HAS BEEN SEEN THAT IF THE SINGLES COUNT RATE EXCEEDS THESE VALUES, THERE COULD BE ARTIFACTS IN THE PROCESSED DATA FOR MCD STUDIES. THERE WAS ALSO AN ASSOCIATED REPORT OF SYSTEM LOCK-UP AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANTAGE NUCLEAR MEDICINE EQUIPMENT IYX ADAC LABORATORIES 2146-3260A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *