BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA HD

    MDR report key: 11716454 · Received April 23, 2021

    Report

    Report Number
    9617016-2021-00002
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 25, 2021
    Report Date
    September 9, 2021
    Manufacturer
    ELEKTA LTD
    Product Code
    IYE
    PMA / PMN Number
    K192242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. EVIDENCE FROM THE HEAD INSPECTION AND TESTING SHOWED THAT THE TANTALUM CAPACITOR ON THE DLG DRIVE BOARD RECEIVED A SIGNIFICANT POWER SPIKE CAUSING IT TO IGNITE. THE HEAT GENERATED WAS SUFFICIENT FOR THE SOLDER TO MELT AND THE CAPACITOR TO FALL AWAY FROM THE BOARD. THE ORIENTATION AND POSITION OF THE BOARD COUPLED WITH THE LINAC GANTRY ANGLE ALLOWED THE CAPACITOR TO FALL ONTO THE INTERNAL SURFACE OF THE SCREEN. THE ACCESSORY RING SCREEN MATERIAL FLAMMABILITY WAS INSUFFICIENT TO STOP THE SPREAD OF THE FIRE. THE ANGLE OF THE GANTRY DURING DELIVERY ALLOWED THE FLAMES TO SPREAD QUICKLY ACROSS THE SCREEN AND DRIP MOLTEN PLASTIC ON TO THE PATIENT. THE MANUFACTURER CONDUCTED A RISK ASSESSMENT WHICH CONCLUDED A SEVERITY OF MODERATE AND PROBABILITY OF IMPLAUSIBLE WHICH IS WITHIN THE ACCEPTABLE REGION. ALTHOUGH THERE WAS AN ACTUAL PATIENT INJURY, IT DID REQUIRE MULTIPLE CASUAL FACTORS TO ENABLE THE FLAMING COMPONENT TO REACH THE CROSSWIRE SCREEN AND CATCH IT ALIGHT. THE GANTRY ANGLE WAS ALSO KEY IN ALLOWING THE FLAMING COMPONENT AND SUBSEQUENT FLAMING PARTICLES FROM THE CROSSWIRE SCREEN TO REACH THE PATIENT. THE PATIENT'S MINOR SCALDS WERE TREATED IMMEDIATELY. FOR FUTURE PRODUCT RELEASE THE MANUFACTURER IS PLANNING TO REVISE THE DESIGN AND RE-ISSUE THE AGILITY DYNAMIC LEAF GUIDE AND DIAPHRAGM DRIVE BOARDS PT NO. 1526647, SO THAT TANTALUM TYPE CAPACITORS ARE ELIMINATED. ESTIMATED END OF (B)(6) 2022.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AGILITY HEAD CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617641 VERSA HD ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD

    Patients

    Seq Age Sex Outcome Treatment
    1