BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLETRON NPS

    MDR report key: 92129 · Received May 16, 1997

    Report

    Report Number
    1121753-1997-00021
    Event Type
    Malfunction
    Date Received
    May 16, 1997
    Date of Event
    January 25, 1997
    Report Date
    May 14, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DECAY FACTOR FOR THE SOURCE IS NOT TAKEN INTO ACCOUNT WHEN RECALLING AN EXISTING PATIENT FILE AND WHEN NO TREATMENT PARAMETERS ARE CHANGED;I.E., WHEN RECALLING AN EXISTING FILE THE ORIGINAL SOURCE STRENGTH AND PARAMETERS ARE DISPLAYED AND ARE USED FOR TREATMENT PURPOSES. NOTE: THIS PROBLEM WAS PREVIOUSLY REPORTED AS 1121753-1997-0005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLETRON NPS RADIOTHERAPY TREATMENT PLANNING SYSTEM IWB NUCLETRON CORP. NPS BPS - MPS *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other