BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATO BPS

    MDR report key: 84380 · Received April 14, 1997

    Report

    Report Number
    1121753-1997-00006
    Event Type
    Malfunction
    Date Received
    April 14, 1997
    Date of Event
    December 4, 1996
    Report Date
    April 9, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INCORRECT CALCULATION OF SOURCE DECAY IS POSSIBLE IF, DURING MANUAL PROGRAMMING OF THE MHDR UNIT, THE TREATMENT PLAN IS PRE-PREPARED, THE TREATMENT DATE IS ENTERED AND THIS DATE IS EARLIER THAN THE SOURCE CALIBRATION DATE. IF THESE PARAMETERS ARE ENTERED IN THIS ORDER, THE SOURCE ACTIVITY IS DECAYED RATHER BEING CORRECTED FOR DECAY. THIS DOES NOT OCCUR IF THE PROGRAM CARD IS UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATO BPS RADIOTHERAPY TREATMENT PLANNING SYSTEM IWB NUCLETRON CORP. PLATO BPS V 13.0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other