BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ACCELERATOR

    MDR report key: 29403 · Received January 22, 1996

    Report

    Report Number
    MW1008135
    Event Type
    Malfunction
    Date Received
    January 22, 1996
    Date of Event
    January 3, 1996
    Report Date
    January 4, 1996
    Manufacturer
    SIEMENS MEDICAL LABORATORIES, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    SIEMENS MEDICAL SYSTEMS, INC. 4040 NELSON AVE, CONCORD, CA 94520. THE REPORT STATES THAT A LOWER THAN DESIRED DOSE WAS DISPLAYED AT THE ACCELERATOR CONSOLE, AND ALSO AT THE LANTIS RECORD AND VERIFY SYSTEM PRIOR TO THE START OF TREATMENT. THE INCORRECT VALUE WAS NOTICED AND REJECTED BY THE OPERATOR, WHO THEN REENTERED THE FIELD. THE CORRECT VALUE THEN APPEARED. IT IS THE PRIMARY FUNCTION OF RECORD AND VERIFICATION SYSTEMS SUCH AS LANTIS TO COMPARE TREATMENT PARAMETERS AS THEY APPEAR ON THE TREATMENT SCREEN, AGAINST THE TREATMENT PRESCRIPTION AS PROGRAMMED INTO THE LANTIS PT DATASBASE. IF DISPLAYED VALUED DO NOT AGREE WITH PRESCRIBED VALUES, TREATMENT MAY NOT PROCEED UNLESS DELIBERATE OVERRIDE PROCEDURES ARE INITIATED. A THOROUGH SYSTEM INSPECTION WAS PERFORMED AT THE USER'S SITE TO DETERMINE THE CAUSE OF THE REPORTED LOW PRESET DOSE INDICATION. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED BY SVC PERSONNEL. AS A PRECAUTION, A CIRCUIT BOARD WHICH COULD CAUSE SUCH A SYMPTOM, WHERE IT COULD MALFUNCTION, WAS REPLACED. SINCE THAT TIME, THE SYMPTOM HAS NOT RECURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR ACCELERATOR LINEAR ACCELERATOR IYE SIEMENS MEDICAL LABORATORIES, INC. KD2

    Patients

    Seq Age Sex Outcome Treatment
    1 *