BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEVATRON KD-2 LINEAR ACCELERATOR

    MDR report key: 902810 · Received August 24, 2007

    Report

    Report Number
    2910081-2007-00020
    Event Type
    Malfunction
    Date Received
    August 24, 2007
    Date of Event
    June 28, 2007
    Report Date
    August 20, 2007
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K862339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL COMPLAINT: "WATER LEAK IN GANTRY AT TARGET FLOW SENSOR SHORTED OUT COIL OF G55-K1 RELAY FOR STEERING CURRENT REVERSAL CIRCUIT, AND RELAY REMAINED IN DE-ENERGIZED STATE. THIS CAUSED STEERING POLARITY FOR ELECTRON ENERGIES TO BE APPLIED WITH 6MV X-RAY PROGRAMMED, AND BEAM OUTPUT WAS SUBSTANTIALLY AFFECTED DURING TREATMENTS. NUMBER (#2) TREATMENT TIME INTERLOCK WAS ASSERTED AT NEAR END OF TREATMENTS. FLATNESS & SYMMETRY INTERLOCKS DID NOT TRIP, DUE TO ORIGINAL MACHINE FWI & SWI WINDOW SETTINGS OF 8.9 & 5.0." THIS PROBLEM OCCURRED DURING PATIENT TREATMENT, BUT THE INITIAL COMPLAINT DOES NOT INDICATE HARM TO PATIENT. THIS MATTER IS CURRENTLY BEING INVESTIGATED, ALONG WITH ROOT CAUSE AND APPROPRIATE CORRECTIVE ACTION. A RISK ANALYSIS IS ALSO GOING TO BE CONDUCTED TO DETERMINE POTENTIAL HARM TO PATIENT AND OPERATOR. THIS FAULT IS CURRENTLY BEING INVESTIGATED AND AN UPDATE TO THE AGENCY WILL BE MADE ONCE FURTHER INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEVATRON KD-2 LINEAR ACCELERATOR MEVATRON KD-2 IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 9822685

    Patients

    Seq Age Sex Outcome Treatment
    1 YR