BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOMOTHERAPY HI-ART TREATMENT SYSTEM

    MDR report key: 6817939 · Received August 24, 2017

    Report

    Report Number
    3003873069-2017-00010
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 9, 2017
    Manufacturer
    ACCURAY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K112776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COUCH EXPERIENCED AN UNEXPECTED DESCENT OF ~2IN WHILE OPERATING THE COUCH VIA CCK. A PATIENT WAS ON THE TABLE AT THE TIME OF THE INCIDENT BUT NO INJURY IS REPORTED. THE (B)(4) DID NOT SHOW BURN DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598391 TOMOTHERAPY HI-ART TREATMENT SYSTEM TOMOTHERAPY TREATMENT SYSTEM IYE ACCURAY INCORPORATED H-0000-0003

    Patients

    Seq Age Sex Outcome Treatment
    1