BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIART SYSTEM

    MDR report key: 1685809 · Received May 11, 2010

    Report

    Report Number
    3003873069-2010-00002
    Event Type
    Malfunction
    Date Received
    May 11, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 11, 2010
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K082005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DESIGN ANOMALY IN SW 2.4 AND 3.XX.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY STARTED THE PATIENT TREATMENT AND THE RAD ON INDICATORS WERE ACTIVE. AT 1:16 SECONDS INTO THE TREATMENT, THE USER NOTICED THERE WERE NO MU'S DISPLAYED AND THE ELAPSED TIME WAS NOT PRESENT ON THE OPERATOR STATION. USER STOPPED THE SYSTEM BUT WAS UNABLE TO GENERATE A COMPLETION PROCEDURE. ON (B)(6), THE USER RETREATED THE PATIENT TO ENTIRETY, WHICH INCLUDED RETREATMENT OF THE FIRST 1:16 SECONDS THAT WAS DELIVERED ON (B)(6). ONCE THIS WAS DISCOVERED, A SUBSEQUENT FRACTION WAS MODIFIED BY TOMOTHERAPY TO ACCOUNT FOR THE ADDITIONAL 1:16 SECOND TREATMENT, THUS ALLOWING THE REMAINING FRACTIONS TO BE DELIVERED AS PLANNED AND NOT POSING A RISK TO THE PATIENT. TOMOTHERAPY HAS ADDRESSED THIS CONDITION IDENTIFIED IN URGENT MEDICAL DEVICE NOTICE DATED AUGUST 10, 2009 AND CORRECTED IN THE 3.1.5/3.2.3 SW UPGRADE WHICH WAS RELEASED ON NOVEMBER 16, 2009. THIS PARTICULAR CUSTOMER SITE HAS YET TO BE UPGRADED BY THE DISTRIBUTOR. ALL HI-ART CUSTOMERS IN THE UNITED STATES HAVE RECEIVED THE 3.1.5/3.2.3 SW UPGRADE.

    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