BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC LINEAR ACCELERATOR

    MDR report key: 16037 · Received September 12, 1994

    Report

    Report Number
    MW1003312
    Event Type
    Malfunction
    Date Received
    September 12, 1994
    Report Date
    August 25, 1994
    Manufacturer
    VARIAN ASSOC., INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON FOUR SEPARATE OCCASIONS (6/28, 7/7, 7/8 AND 8/25/94) WITH ACCELERATOR TREATMENT RATE SET TO 250 MU/MIN, THE ACTUAL TREATMENT DELIVERY RATE ROSE TO BETWEEN 291 AND 299 MU/MIN. THIS DOSE DELIVERY RATE CORRESPONDS TO AN UNSERVOED DOSE RATE. ALL AFFECTED TREATMENTS WERE ADMINISTERED AT THE PROPER DOSE, ONLY AT A FASTER RATE. (ACTUAL RATE OF DELIVERY WAS VERIFIED WITH AN EXTERNAL MONITORING SYSTEM.) THE MFR WAS CONTACTED UPON THE FIRST OCCURRENCE. THE MALFUNCTION OCCURS INTERMITTENTLY AND WITH NO APPARENT PATTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR RADIOTHERAPY ACCELERATOR IYE VARIAN ASSOC., INC. CL-600C

    Patients

    Seq Age Sex Outcome Treatment
    1 *