BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 480136 · Received August 19, 2003

    Report

    Report Number
    2914292-2003-00008
    Event Type
    Malfunction
    Date Received
    August 19, 2003
    Date of Event
    July 11, 2003
    Report Date
    August 18, 2003
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT BETWEEN 16H08 AND 17H01 IN 2003, 10 OUT OF 31 MEASUREMENTS FELL INTO THE 25-30% UNDER RECORDING ZONE; FURTHERMORE THEY REPORTED THAT THERE WAS A POSSIBLE PALLIATIVE PATIENT MISTREATMENT OF APPROXIMATELY 27% UNDEREXPOSURE, AS A RESULT. ATTEMPTS TO FURTHER CLARIFY SPECIFIC PATIENT DETAILS AND THE LEVELS OF POTENTIAL AFFECTS HAVE NOT BEEN SUCCESSFUL; THEREFORE COMPANY IS REPORTING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS, INC. 600C *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other