BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE DIGITAL ACCELERATOR

    MDR report key: 3798834 · Received May 8, 2014

    Report

    Report Number
    9617016-2014-00008
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ELEKTA LTD
    Product Code
    IYE
    PMA / PMN Number
    K963624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING. ELEKTA WILL PROVIDE FURTHER INFORMATION WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S ANALYSIS INDICATES EVERY BEAM WAS BEING DELIVERED WITHIN SPECIFICATION AND THAT NO SAFETY ISSUE EXISTS. IT DOES NOT HOWEVER, EXPLAIN WHY THE CUSTOMER'S OPEN CONE OUTPUT FACTOR MEASUREMENTS WERE LOWER THAN EXPECTED NOR THE STRANGE APPLICATOR SIZE ON THE INTEGRITY SCREEN. THE MANUFACTURER PERFORMED VARIOUS EXPERIMENTS BUT WAS UNABLE TO REPRODUCE THE FAULT. THE DEVICE WAS WORKING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THERE HAS BEEN NO ADVERSE EVENT. DURING COMMISSIONING THE CUSTOMER WAS MEASURING OPEN CONE OUT FACTORS (RELATIVE TO 10X10 CONE), IT WAS NOTICED THAT THE 20X20 CONE FACTORS WERE REALLY LOW, APPROX 10-12% LOWER THAN EXPECTED. THE CUSTOMER LOOKED AT THE LIGHT FIELD ON THE CONE, AND NOTICED THAT THE LIGHT FIELD WAS NOT HITTING THE CUTTERS IN THE INLINE (GUN --> TARGET) DIRECTION (G=0, AND COLL=0). BUT THE LINAC ALLOWED THEM TO BEAM ON (THE MACHINE WAS IN INTERLOCK 0/1, NOT CTRL T), THEY MEASURED ALL ENERGIES WITH THIS CONE (6-18MEV). AT THAT STAGE, THEY LOOKED AT THE AUTO TRACKING FIGURES, WHICH WERE CORRECT, BUT NO CONE ID WAS SHOWN. THE CUSTOMER LOOKED AT THE CORRESPONDING CONE ON ANOTHER MACHINE, AND THE LIGHT FIELD LOOKED AS IT IS SUPPOSED TO LOOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279446 PRECISE DIGITAL ACCELERATOR ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD 153014

    Patients

    Seq Age Sex Outcome Treatment
    1