BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOMOTHERAPY HD

    MDR report key: 6849765 · Received September 7, 2017

    Report

    Report Number
    3003873069-2017-00012
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    March 8, 2017
    Report Date
    March 8, 2017
    Manufacturer
    ACCURAY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K082005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMED THAT MECHANICAL NOISE OCCURRED WHILE ROTATING THE GANTRY. AN FIELD SERVICE ENGINEER (FSE) WAS ON-SITE TO INSPECT THE ISSUE. THE FSE ROTATED THE GANTRY MANUALLY AT 4 RPM USING THE HUMAN MACHINE INTERFACE (HMI) PANEL (THE SLOWEST SPEED THAT COULD REPRODUCE THE NOISE). THE NOISE CAME FROM THE BOTTOM PART OF THE GANTRY, SO THE FSE CROUCHED DOWN NEAR THE GANTRY AND PUT THEIR RIGHT HAND ON THE FLOOR. THE GANTRY HIT THE RIGHT ELBOW OF THE FSE, PINCHING THE RIGHT FOREARM BETWEEN THE GANTRY AND THE FLOOR AND BREAKING THE RIGHT WRIST. THE FIELD SERVICE ENGINEER HAS RETURNED TO WORK. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628613 TOMOTHERAPY HD TOMOTHERAPY TREATMENT SYSTEM IYE ACCURAY INCORPORATED 1018283

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention