BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS

    MDR report key: 1013983 · Received March 12, 2008

    Report

    Report Number
    2910081-2008-00014
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RISK ANALYSIS AND CORRECTIVE ACTION PLAN IS STILL UNDER EVALUATION AND ONCE THE DECISION IS FINALIZED, THE REGULATORY AGENCY WILL BE NOTIFIED.

    Description of Event or Problem · 1

    WE HAVE BECOME AWARE OF A MEDICAL LINEAR ACCELERATOR MALFUNCTION. AFTER INSTALLATION OF SAFETY SOFTWARE UPDATE, THE GANTRY MAY MOVE IN THE WRONG DIRECTION UNDER CERTAIN SPECIFIC CIRCUMSTANCES. THE IDENTIFIED CIRCUMSTANCES ARE: USER IS TREATING IN AUTOSEQUENCE MODE, AND TWO CONSECUTIVE TREATMENT FIELDS ARE TO BE TREATED WITH A GANTRY POSITION BETWEEN 170 AND 190 DEGREES, AND WHEN MOVING THE GANTRY TO THE TREATMENT POSITION FOR THE FIRST OF THE TWO SEGMENTS, THE USER OVERRIDES THE DEFAULT GANTRY ROTATION DIRECTION MANUALLY BY USING THE HAND CONTROL OR THE KEYBOARD, AND THE ACTUAL POSITION OF THE FIRST SEGMENT IS DIFFERENT FROM THE PLANNED POSITION OF THE SECOND SEGMENT. IF ALL THE DESCRIBED CONDITIONS ARE MET, THE GANTRY WILL NOT MOVE IN THE SHORTEST POSSIBLE DIRECTION FROM THE FIRST TO THE SECOND FIELD AS EXPECTED, BUT WILL INSTEAD MOVE THE LONG WAY AROUND THE CIRCLE WHICH WILL RESULT IN A GANTRY ROTATION OF AT LEAST 340 DEGREES AT A SPEED OF UP TO 6 DEGREES PER SECOND. THIS COULD POTENTIALLY LEAD TO A COLLISION WHICH COULD RESULT IN SERIOUS INJURY. ITS IMPORTANT TO NOTE THAT NO INJURY WAS REPORTED AND 'MOTION STOP' IS FUNCTIONAL AT THE CONTROL CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMUS ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS NA

    Patients

    Seq Age Sex Outcome Treatment
    1