BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVALIS

    MDR report key: 593420 · Received April 7, 2005

    Report

    Report Number
    8043933-2005-00001
    Event Type
    Other
    Date Received
    April 7, 2005
    Date of Event
    May 28, 2004
    Report Date
    March 10, 2005
    Manufacturer
    BRAINLAB AG
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MEDICAL CENTER REPORTED THAT BETWEEN 2004 AND 2005 77 PTS RECEIVED RADIATION APPROX 52% IN EXCESS OF THEIR PRESCRIBED DOSE DELIVERED USING THE NOVAILIS LINEAR ACCELERATOR. SEVERAL OF THE MEDICAL CENTER'S REPRESENTATIVES HAVE CONFIRMED THAT THE EXCESS RADIATION WAS A RESULT OF A CALCULATION ERROR BY THE MEDICAL CENTER PHYSICIST DURING CALIBRATION OF THE NOVALIS LINEAR ACCELERATOR AND NOT BY ANY FAILURE OR MALFUNCTION OF THE NOVAILIS. THE INITIAL AND ALL SUBSEQUENT DOSIMETRY CALIBRATION CALCULATIONS OF THIS, AND EVERY OTHER, MEDICAL LINEAR ACCELERATOR IS THE RESPONSIBILITY OF THE DEVICE OWNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVALIS MEDICAL LINEAR ACCELERATOR IYE BRAINLAB AG NOVALIS *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other