BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMOTHERAPY HI-ART TREATMENT SYSTEM

    MDR report key: 7047496 · Received November 20, 2017

    Report

    Report Number
    3003873069-2017-00016
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 25, 2017
    Report Date
    October 25, 2017
    Manufacturer
    ACCURAY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K112776
    Removal / Correction Number
    3003873069/11/15/2017/00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURAY HAS IDENTIFIED AN ISSUE THAT RELATES TO THE HIGH-PERFORMANCE PATIENT COUCH. UNDER CERTAIN CIRCUMSTANCES WHEN THE USER INITIATES PATIENT COUCH MOTION IN THE Z-DIRECTION FOR PATIENT SETUP OR PATIENT UNLOADING USING THE KEYPAD OR POSITIONING CONTROL PANEL (PCP) IT MAY EXHIBIT UNINTENDED DESCENT. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE THE CONTROL SYSTEM'S HANDLING OF THE MOTION FEEDBACK LOSS WITHIN THE VERTICAL DRIVE ACTUATOR. ACCURAY HAS INITIATED A FIELD CORRECTION TO ADDRESS THIS ISSUE WITHIN 3003873069/11/15/2017/001C IN THE FORM OF A SOFTWARE PATCH AND REPLACEMENT OF CABLES WITHIN THE COUCH SUBSYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COUCH HAD AN UNEXPECTED DESCENT OF ~15 CM WHILST THE CUSTOMER WAS COMMANDING AN UPWARDS MOVE VIA COUCH CONTROL KEYPAD (CCK). BURN MARKS WERE OBSERVED ON THE BRAKING RESISTOR BOARD (BRB). NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825275 TOMOTHERAPY HI-ART TREATMENT SYSTEM TOMOTHERAPY TREATMENT SYSTEM IYE ACCURAY INCORPORATED 104430

    Patients

    Seq Age Sex Outcome Treatment
    1