BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUENCER

    MDR report key: 1051316 · Received May 23, 2008

    Report

    Report Number
    2950347-2008-00003
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 9, 2008
    Report Date
    May 23, 2008
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K981313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPAC HAD DETERMINED THAT THIS ISSUE MAY POTENTIALLY AFFECT SITES, DESPITE A VERY REMOTE PROBABILITY OF OCCURRENCE, IMPAC DECIDED TO TAKE CORRECTIVE ACTION IN THE FIELD TO ALERT POTENTIALLY AFFECTED CUSTOMERS OF THE ISSUE AND OFFER THEM A SOLUTION FOR THE ISSUE. THUS, THE EVENT ITSELF DID NOT MEET THE MDR THRESHOLD, BUT BECAUSE IT INVOLVES A DEFECT FOR WHICH IMPAC IS TAKING CORRECTIVE FIELD ACTION, AN MDR IS NOW REQUIRED PER PART 803.3.

    Description of Event or Problem · 1

    FOR A FULL DESCRIPTION OF THE PRODUCT PROBLEM AND RELATED REMEDIAL ACTION, IMPAC HAS IDENTIFIED A POTENTIAL SAFETY ISSUE WITH ITS VARIAN STANDARD SCALE 4D MACHINE CHARACTERIZATION TEMPLATE. THE DEFECT IN THAT TEMPLATE AFFECTS THE IMPORT OF RTP FORMAT (NON-DICOM) TREATMENT PLANS AND MAY AFFECT THE TRANSFER OF TREATMENT PLANS FROM VARIAN 4D MACHINES TO NON-4D MACHINES THAT ARE GEOMETRICALLY EQUIVALENT. UNDER CERTAIN CIRCUMSTANCES, IT RESULTS IN THE FLIPPING OF THE MLC LEAF 1 OF SIDE 1 FROM TOP LEFT TO BOTTOM RIGHT, THUS ROTATING THE MLC LEAF PLAN 180 D. INVESTIGATION HAS BEEN CONCLUDED AND COURSE OF ACTION IDENTIFIED. A LIST OF CUSTOMERS, WITHIN THE SPECIFIED PRODUCT VERSION RANGE, IN THE FIELD WITH 4D MACHINES HAS BEEN COMPILED AND IMPAC IS IN THE PROCESS OF SENDING A NOTIFICATION REGARDING THE INCORRECT MACHINE CHARACTERIZATION, TO THE IDENTIFIED AFFECTED SITES. THE LETTER OFFERS THE SITES SOME RECOMMENDED RESOLUTIONS, WHICH ARE ESSENTIALLY CORRECTIONS TO THE CONFIGURATION TO THE MLC. THE PERMANENT FIX TO THE PROBLEM WILL BE IN THE NEWER RELEASES OF MOSAIQ AND MULTI-ACCESS AND ANY SITE REQUESTING FOR AN UPGRADE TO THE NEWER VERSIONS, WILL BE GIVEN ONE EXPEDITIOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUENCER VERIFY & RECORD SYSTEM IYE IMPAC MEDICAL SYSTEMS, INC. 40000-001000-RO

    Patients

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