BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-ART SYSTEM

    MDR report key: 875747 · Received October 27, 2006

    Report

    Report Number
    3003873069-2006-00001
    Event Type
    Malfunction
    Date Received
    October 27, 2006
    Date of Event
    September 26, 2006
    Report Date
    October 27, 2006
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    MUJ
    PMA / PMN Number
    k060912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DETAILS CONCERNING THE INVESTIGATION RESULTS AND CORRECTIVE ACTION WILL BE PROVIDED IN A FOLLOW-UP REPORT WHEN AVAILABLE. DEVICE PROCEDURE LOG FILE EVALUATED. EVALUATION CODES ARE PRELIMINARY AND SUBJECT TO CHANGE UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AFTER PERFORMING A PATIENT SCAN AND PRIOR TO PATIENT REGISTRATION ON A TOMOTHERAPY HI-ART SYSTEM, THE USER REPORTED THAT THE IMAGE OF THE PATIENT DISPLAYED ON THE OPERATOR WORKSTATION WAS NOT THE PATIENT THAT WAS JUST SCANNED. THE IMAGE DISPLAYED WAS OF THE PATIENT THAT HAD RECEIVED A TREATMENT FRACTION PRIOR TO THE SCANNING OF THE CURRENT PATIENT. THE USER NOTICED THE IMAGE DISCREPANCY, RESTARTED THE OPERATOR WORKSTATION COMPUTER, PERFORMED THE PATIENT SCAN AGAIN AND THE IMAGE OF THE SCANNED PATIENT DISPLAYED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-ART SYSTEM IYE AND MUJ MUJ TOMOTHERAPY INCORPORATED H-0000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1