BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAN VARIS RECORD & VERIFY

    MDR report key: 175257 · Received June 30, 1998

    Report

    Report Number
    MW1014094
    Event Type
    Malfunction
    Date Received
    June 30, 1998
    Date of Event
    May 28, 1998
    Report Date
    May 30, 1998
    Manufacturer
    VARIAN ASSOC., INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    ON TWO SEPARATE OCCASIONS, THE VARIS RECORD AND VERIFY SYSTEM HAVE NOT RECORDED A TREATMENT DELIVERED TO A PT. FOR THESE TWO OCCASIONS, THERE IS NO COMMON VARIABLE OTHER THAN THE VARIS SYSTEM. THE ERRORS OCCURRED ON DIFFERENT TREATMENT UNITS, DIFFERENT RADIATION THERAPISTS PERFORMING THE TREATMENT, DIFFERENT TREATMENT DAYS AND DIFFERENT PTS. ERROR #1: TREATMENT UNIT: VARIAN 2100C LINEAR ACCELERATOR; TREATMENT DAY 5/28/98; PROBLEM: THE LAST OF THREE FIELDS TREATED WAS NOT RECORDED; WITNESS, ONLY THE TREATING THERAPIST SAW THE ERROR. ERROR #2: TREATMENT UNIT: VARIAN 600C LINEAR ACCELERATOR; TREATMENT DAY 6/25/98; PROBLEM: THE LAST OF TWO FIELDS TREATED WAS NOT RECORDED; WITNESS, THREE PERSONNEL VERIFIED THE MONITOR UNITS DELIVERED WERE CORRECTLY DEMONSTRATED ON THE LINEAR ACCELERATOR CONTROL CONSOLE BUT THE VARIS DISPLAY DID NOT RECORD THE TREATMENT EVENT. THE ERRORS WERE NOTED BY THE DEPT AND A MANUAL EDIT WAS PERFORMED BY DEPT PERSONNEL OF THE ELECTRON DATA REFLECT THE ACTUAL DOSE. THE DEPT ALSO MAINTAINS A MANUAL DOSE ACCUMULATED RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN VARIS RECORD & VERIFY RADIATION ONCOLOGY COMPUTER SYSTEM IYE VARIAN ASSOC., INC. VARIS *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other