BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCENTRA MASTERPLAN

    MDR report key: 2394728 · Received December 23, 2011

    Report

    Report Number
    9611894-2011-00019
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    March 2, 2010
    Report Date
    December 19, 2011
    Manufacturer
    NUCLETRON, B.V.
    Product Code
    MUJ
    PMA / PMN Number
    K081281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCLUSION OF THE SOURCE TO TRAY DISTANCE IN THE DICOM EXPORT IS IN ACCORDANCE WITH THE DICOM CONFORMANCE STATEMENT. ARIA REFUSED THE DATA BECAUSE OF A DIFFERENCE BETWEEN THE TRAY DISTANCE STORED IN ONCENTRA MASTER PLAN AND ARIA. THERE IS NOTHING IN THE EXPORTED DOSE DATA THAT EXPLAINS THE OVERDOSE.

    Description of Event or Problem · 1

    THE CUSTOMER TRANSFERRED AN RT PLAN FROM OMP TO ARIA. THE PATIENT GOT AN OVERDOSE OF 80% IN FIRST FRACTION. THE WEDGES CHANGED FROM STATIC TO DYNAMIC AND THE CUSTOMER DIDN'T NOTICE IT BEFORE THE TREATMENT. IN THIS RT PLAN TRANSFER, THERE ARE TWO POSSIBLE CASES WHICH CAN HAPPEN: THE WEDGES DO NOT APPEAR AT ALL ON ARIA SIDE WHEN TRANSFERRED FROM OMP TO ARIA. THE WEDGES ARE BADLY INTERPRETED BY ARIA AND THEY ARE TRANSFORMED FROM STATIC TO DYNAMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCENTRA MASTERPLAN OTP SOFTWARE MUJ NUCLETRON, B.V. 170.700-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization