BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATO BPS V. 13.2

    MDR report key: 89529 · Received May 6, 1997

    Report

    Report Number
    1121753-1997-00015
    Event Type
    Malfunction
    Date Received
    May 6, 1997
    Report Date
    April 17, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FOR SOFTWARE V. 13.2, IF AN EXISTING PLAN IS SELECTED, THEN READ IN A AS A CUSTOM FILE WITH DIFFERENT STEP SIZE, THE PROGRAM ALLOWS ONE TO WRITE A PROGRAM WITH A DIFFERENT STEP SIZE THAN THE STEP SIZE ORIGINALLY PROGRAMMED. THE JOURNAL FILE PRINTOUT DISPLAYS THE MESSAGES: (1) "INACCURATE DOSE CALCULATION MAY RESULT" AND (2) PROGRAM CARD IS DISABLED". HOWEVER THE PROGRAM CARD IS NOT DISABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATO BPS V. 13.2 RADIOTHERAPY TX PLANNING SYSTEM IWB NUCLETRON CORP. PLATO BPS *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other