BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ACCELERATOR

    MDR report key: 68208 · Received February 12, 1997

    Report

    Report Number
    MW1010701
    Event Type
    Malfunction
    Date Received
    February 12, 1997
    Report Date
    February 10, 1997
    Manufacturer
    VARIAN ASSOC, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LINEAR ACCELERATOR. RECORD AND VERIFICATION SYSTEM RECORDED. TREATMENT GIVEN TO AN AREA OF THE PT. RECEIVING TREATMENT 2 TIMES INSTEAD OF ONE. THE TIME SEQUENCE OF TREATMENT WAS AS FOLLOWS: 1:15 PM - ANTERIOR SUPRACLAVICULAR, 1:20 PM - RIGHT LAT NECK; 1:23 PM - LEFT LAT NECK; 1:46 PM - ANTERIOR SUPRACLAV. THE PT WOULD HAVE HAD TO LAY ON THE TABLE FOR 23 MINS DURING APP'S. THIS IS AN ERROR OF THE SOFT WARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR ACCELERATOR LINEAR ACCELERATOR IYE VARIAN ASSOC, INC. RMS 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other