BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NPS

    MDR report key: 89524 · Received May 6, 1997

    Report

    Report Number
    1121753-1997-00013
    Event Type
    Malfunction
    Date Received
    May 6, 1997
    Date of Event
    August 9, 1996
    Report Date
    April 16, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOR SOFTWARE VERSION 11.1, A CUSTOMIZING FILE WITH TUBES OF VARYING LENGTH, THE DISPLAY OF THE TUBE LENGTH ON THE SCREEN AND PLOT CAN BE INCORRECT. THIS OCCURRS IF THE FIRST CUSTOMIZED TUBE IS NOT SELECTED, SINCE THE FIRST TUBE IS ALWAYS USED FOR THE DISPLAY OF THE TUBE LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NPS RADIOTHERAPY TX PLANNING SYSTEM IWB NUCLETRON CORP. MLDR/SEED V 11.1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other