BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISTE MV SYSTEM

    MDR report key: 2945109 · Received December 28, 2012

    Report

    Report Number
    2910081-2012-11136
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 29, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY
    Product Code
    IYE
    PMA / PMN Number
    K090683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED INCIDENT IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE INVESTIGATION. CUSTOMER ADDRESS: (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED (B)(6) 2012 THAT THERE WAS A SHORT IN THE G41 MOTHERBOARD NEAR THE TB1 PIN 12 AREA THAT CAUSED A FIRE AND BURNED THE HEAD DRIVER CAUSING AN INVOLUNTARY MOVEMENT OF THE GANTRY. REPORTEDLY, WHEN THE FIRE ARRIVE AT THE HEAD DRIVER BOARD, THE GANTRY STARTED MOVING W/O COMMAND IN THE CLOCKWISE DIRECTION UNTIL IT REACHED THE LIMIT. THE SYSTEM WAS DE-ENERGIZED AND THE FIRE DISAPPEARED. BOARD G42, G41 MOTHERBOARD, G41 HEAD DRIVER AND G41 INTERLOCK BOARD WERE BURNT ALONG WITH A LOT OF CABLES AROUND THE AREA. THER IS NO REPORT OF INJURY OR MISTREATMENT TO A PT. THIS REPORTED ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISTE MV SYSTEM ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY 08139789 NA

    Patients

    Seq Age Sex Outcome Treatment
    1