BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUENCER

    MDR report key: 996569 · Received February 8, 2008

    Report

    Report Number
    2950347-2008-00001
    Event Type
    Injury
    Date Received
    February 8, 2008
    Date of Event
    January 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K981313
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPAC PRODUCT DEVELOPMENT IS CURRENTLY WORKING ON A FIX WHICH SHALL BE MADE AVAILABLE TO AFFECTED CUSTOMERS. NO PATIENTS ARE KNOWN TO HAVE BEEN MISTREATED OR INJURED DUE TO THIS POTENTIAL ERROR, WHICH WAS CAUGHT DURING THE QA CHECK DONE PRIOR TO TREATMENT.

    Description of Event or Problem · 1

    DURING THE COURSE OF A TREATMENT USING IMPAC'S SEQUENCER, RECORD AND VERIFY SYSTEM, AN UNINTENDED CHANGE OCCURRED WHILE THE USER WAS EDITING THE MACHINE IN THE FIELD DEFINITION MODE IN 2008. THIS UNINTENDED CHANGE OCCURRED AS THE RESULT OF A CHANGE FROM MACHINE "A" TO A DIFFERENT MACHINE IN ORDER TO CONTINUE A TREATMENT ON MACHINE "B." THE CHANGE TO A DIFFERENT MACHINE RESULTED IN THE IMRT FIELD AND THE X/Y JAWS OF CERTAIN FIELD CONTROL POINTS TO CHANGE FROM ASYM (ASYMMETRICAL) TO SYM (SYMMETRICAL). IT HAS BEEN DETERMINED THAT IF THE X AND Y JAWS OF THE CONTROL POINT ARE SYM WHEN A MACHINE CHANGE TAKES PLACE, THEN THE X/Y JAWS OF FOLLOWING CONTROL POINTS WILL BE SET TO SYM, ALTHOUGH THE X/Y JAWS OF OTHER CONTROL POINTS IN THE FIELDS SHOULD BE ASYM. THIS COULD RESULT IN A PORTION OF THESE CONTROL POINTS BEING BLOCKED BY THE NOW SYMMETRIC JAW. IN ADDITION, IF THE USER HAS A MACHINE CHARACTERIZATION LEAF CONFIGURATION THAT RESULTS IN A LEAF GAP, THE NORMAL TISSUE OUTSIDE THE CONTROL POINT COULD BE EXPOSED. THE ERROR HAS BEEN DETERMINED TO AFFECT ONLY ELEKTA AND SIEMENS MACHINES RUNNING MOSAIQ VERSIONS 1.3 AND 1.4. A FIELD NOTIFICATION SHALL BE SENT TO THOSE CUSTOMERS WHO MAY POTENTIALLY BE AFFECTED BY THIS ANOMALY IN ORDER TO WARN OF THE POTENTIAL RAMIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUENCER RECORD AND VERIFY SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC. 40003-001000-RO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other RADIATION THERAPY TREATMENT SYSTEM (MANY DEVICES)