BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIART SYSTEM

    MDR report key: 1556503 · Received December 7, 2009

    Report

    Report Number
    3003873069-2009-00010
    Event Type
    Malfunction
    Date Received
    December 7, 2009
    Date of Event
    November 16, 2009
    Report Date
    December 7, 2009
    Manufacturer
    TOMOTHERAPY INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K060912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    USER REPORTED DURING A TREATMENT PROCEDURE, THERE WERE NO MU VALUES DISPLAYED ON THE OPERATOR STATION DISPLAY. A SHORT TIME LATER, A HIART SYSTEM ERROR MESSAGE OCCURRED. THE USER THEN DECIDED TO STOP THE PROCEDURE, BUT WAS UNABLE TO GENERATE A COMPLETION PROCEDURE AT THAT POINT. USER DID NOT KNOW HOW LONG THE PT WAS TREATED. USER IMMEDIATELY CONTACTED TOMOTHERAPY. 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. TO CORRECT THIS, THE PT XML FILE WAS MODIFIED BY TOMOTHERAPY SO THE USER COULD GENERATE A COMPLETION PROCEDURE FROM THE TIME WHEN THE INTERRUPT OCCURRED. THERE WAS NO PT INJURY. 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.

    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