BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9.2 PINNACLE3 SW

    MDR report key: 3902576 · Received May 9, 2014

    Report

    Report Number
    3004022368-2014-00002
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MUJ
    PMA / PMN Number
    K041577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B(4). DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. NEITHER WE NOR THE USER CAN REPRODUCE THIS CONSISTENTLY, ALTHOUGH THEY HAVE PROVIDED A PLAN DEMONSTRATING THIS BEHAVIOR. INSPECTION OF THE FINAL PLAN SHOWS THAT THE SEGMENT SHAPES ARE MUCH SMALLER AND MORE IRREGULAR THAN THE ORIGINAL PLAN, WHICH MAY EXPLAIN THE HIGH MONITOR UNITS. WE HAVE INSUFFICIENT INFORMATION TO DETERMINE IF THE PRODUCT ACTUALLY MALFUNCTIONED OR IF IT WAS USE ERROR. ALSO, WE CANNOT DETERMINE IF THIS WOULD LIKELY CAUSE SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. INVESTIGATION IS INCONCLUSIVE. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE COMPLETED.

    Description of Event or Problem · 1

    THE WORKFLOW DESCRIBED IN THE COMPLAINT INVOLVES SEVERAL STEPS. THE USER CREATED AND OPTIMIZED A VMAT PLAN WITH TWO ARCS USING 4 DEGREE ANGULAR SPACING, USED THE "INTERPOLATE" FUNCTION TO SET THE ARC RESOLUTION TO 2 DEGREES, AND THEN DID PERFORMED A "WARM START" OPTIMIZATION (STARTING THE OPTIMIZATION FROM THE CURRENT STATE, AS OPPOSED TO RESETTING THE BEAMS AND STARTING OVER). UPON COMPLETING OPTIMIZATION, THE MONITOR UNITS (MU) WERE APPROXIMATELY DOUBLE THOSE OF THE ORIGINAL PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282245 9.2 PINNACLE3 SW MUJ PHILIPS MEDICAL SYSTEMS 459800091001

    Patients

    Seq Age Sex Outcome Treatment
    1