BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIART SYSTEM

    MDR report key: 1578943 · Received January 4, 2010

    Report

    Report Number
    3003873069-2009-00011
    Event Type
    Malfunction
    Date Received
    January 4, 2010
    Date of Event
    December 9, 2009
    Report Date
    January 4, 2010
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K060912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS AT THE START OF TREATMENT THERE WERE NO MU VALUES AND ELAPSED TIME DISPLAYED ON THE OPERATOR STATION (OS). AFTER APPROX 50 SECS OF TREATMENT, THE USER STOPPED THE PROCEDURE. THE USER COULD NOT GENERATE A COMPLETION PROCEDURE AT THAT POINT. CUSTOMER RESTARTED THE PROCEDURE AND IT STARTED FROM THE BEGINNING. THE PT RECEIVED AN EXTRA 50 SECS OF RADIATION BECAUSE THE ENTIRE PROCEDURE WAS DELIVERED. INVESTIGATION OF THE SYSTEM LOGS BY TOMOTHERAPY REVEALED THE HIART SYSTEM DID NOT UPDATE THE PROCEDURE FROM A "SCHEDULED" TO AN "INTERRUPTED" STATUS AT THE START OF THE PROCEDURE. TOMOTHERAPY IS AWARE OF THIS ANOMALY AND SENT OUT A SAFETY NOTICE (# 4722) DATED 8/10/09 ALERTING USERS. SOFTWARE 3.1.5 AND 3.2.3. HAS SINCE BEEN RELEASED WHICH ADDRESSES THE ANOMALY. SINCE THIS REPORT, THE CUSTOMER'S SYSTEM HAS BEEN UPGRADED TO 3.2.3 SW. THE CUSTOMER CONFIRMED THE AMOUNT OF OVER TREATMENT DID NOT POSE ANY RISK TO THE PT.

    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