BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DICOM

    MDR report key: 295713 · Received September 5, 2000

    Report

    Report Number
    2916556-2000-00324
    Event Type
    Malfunction
    Date Received
    September 5, 2000
    Date of Event
    August 16, 2000
    Report Date
    August 24, 2000
    Manufacturer
    ADAC LABORATORIES
    Product Code
    LMD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO ADAC THAT IN SOME INSTANCES, TRANSFERED DATA FROM DIFFERENT PEGASYS SYSTEMS (NOT ON AN ADAC NETWORK) IS NOT ASSIGNED A UNIQUE ID. THIS CAUSES THE DATA TO BE REJECTED BY DICOM. THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DICOM NUCLEAR MEDICINE EQUIPMENT LMD ADAC LABORATORIES 9104-0044A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN