BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIART SYSTEM

    MDR report key: 1571344 · Received December 8, 2009

    Report

    Report Number
    3003873069-2009-00009
    Event Type
    Malfunction
    Date Received
    December 8, 2009
    Date of Event
    November 10, 2009
    Report Date
    November 23, 2009
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K060912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL SOFTWARE CODE USED IN DEVICE EVALUATED. TOMOTHERAPY CONDUCTED A REVIEW OF THE AMOUNT OF PT MOVES AND ROLL CORRECTIONS PERFORMED AT THE ONE SITE WHICH IS USING THIS SOFTWARE REVISION. IN EACH CASE TO DATE, THE AMOUNT OF POSITIONING ERROR WAS LESS THAN 2.8MM.

    Description of Event or Problem · 1

    THE HIART SYSTEM PROVIDES THE ABILITY FOR PT PLAN IMAGES AND DQA IMAGES TO BE MOVED LATERALLY AND VERTICALLY. SEPARATELY, THE HIART SYSTEM ALSO PROVIDES THE OPTIONAL ABILITY TO APPLY AUTOMATIC TREATMENT GANTRY ROLL CORRECTION AT DELIVERY TIME TO ADJUST FOR PT POSITION. IN THE EVENT A PT OR DQA PLAN HAS AN IMAGE MOVE APPLIED, AND IF OPTIONAL ROLL CORRECTION IS SUBSEQUENTLY APPLIED DURING REGISTRATION, THE ROLL CORRECTION WILL BE INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIART SYSTEM IYE AND MUJ IYE TOMOTHERAPY INCORPORATED H-0000-0003

    Patients

    Seq Age Sex Outcome Treatment
    1