BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON

    MDR report key: 189539 · Received September 25, 1998

    Report

    Report Number
    1423253-1998-00005
    Event Type
    Malfunction
    Date Received
    September 25, 1998
    Date of Event
    August 28, 1998
    Report Date
    September 25, 1998
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC. NMG GROUP
    Product Code
    JWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REINSTALLATION OF SOFTWARE CAUSES USER DEFINED CORRECTION FACTORS FOR THE THYROID UPTAKE AND MAG 3 PROGRAMS TO REVERT BACK TO THE MFR DEFAULT FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICON COMPUTER JWM SIEMENS MEDICAL SYSTEMS, INC. NMG GROUP 4348913 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other