BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NPS-BPS MPS/PPS

    MDR report key: 89522 · Received May 6, 1997

    Report

    Report Number
    1121753-1997-00016
    Event Type
    Malfunction
    Date Received
    May 6, 1997
    Date of Event
    July 6, 1994
    Report Date
    April 16, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    FOR SOFTWARE V 8.12, SPECIFIED ACTIVITY IS NOT CORRECT AFTER CHANGING WEIGHTS. THE DWELL WEIGHTS ARE ASSUMED TO BE RELATIVE FACTORS NORMALIZED TO 1. IF, HOWEVER, INSTEAD OF 1 ALL DWELL WEIGHTS ARE CHANGED TO 0.5, THE REFERENCE DOSE RATE IS MULTIPLIED BY 0.5, AND ALL TIMES ARE CORRECTLY MULTIPLIED BY 2. IF ONE OR MORE DWELL WEIGHTS ARE NOW CHANGED, BUT TO THE SAME VALUE (0.5), THE REFERENCE DOSE RATE BASED ON 0.5 IS AGAIN MULTIPLIED BY 0.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NPS-BPS MPS/PPS RADIOTHERAPY TREATMENT PLANNING SYS IWB NUCLETRON CORP. MPS V 8.12 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other