BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NPS

    MDR report key: 89485 · Received May 6, 1997

    Report

    Report Number
    1121753-1997-00005
    Event Type
    Malfunction
    Date Received
    May 6, 1997
    Date of Event
    September 17, 1996
    Report Date
    April 9, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOR SOFTWARE SEED VERSIONS V. 11.0 AND V. 11.1, A SOURCE DECAY CALCULATION IS NOT PERFORMED WHEN AN EXISTING PATIENT FILE IS RECALLED AND WHEN THE PATIENT TREATMENT PARAMETERS CONTAINED IN THAT FILE ARE UNCHANGED. IN THIS SITUATION, THE ORIGINAL TREATMENT PARAMETERS ARE DISPLAYED, INCLUDING THE ORIGINAL SOURCE STRENGTH, AND A SOURCE DECAY CALCULATION TO CORRECT SOURCE DAY TO THE ACTUAL TIME OF TREATMENT WILL NOT BE UTILIZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other