BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON

    MDR report key: 200865 · Received December 2, 1998

    Report

    Report Number
    1423253-1998-00008
    Event Type
    Malfunction
    Date Received
    December 2, 1998
    Date of Event
    November 12, 1998
    Report Date
    November 12, 1998
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC. NMG GROUP
    Product Code
    JWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NUCLEAR MEDICINE TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    UNDER CERTAIN CONDITIONS, THE AUTOPERFUSION PROGRAM MAY SAVE INCORRECT DATA INTO THE OBLIQUE FILE. THIS PROBLEM MAY BE SEEN WHEN PROCESSING GATED SPECT DATA BY ITSELF OR IN CONJUNCTION WITH NON-GATED DATA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other