BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS BRAND NAME: ARTISTE MV

    MDR report key: 1981186 · Received January 31, 2011

    Report

    Report Number
    2910081-2011-00002
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    December 10, 2010
    Report Date
    January 10, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K072485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY RISK ASSESSMENT INDICATES: SEVERITY: 3 (CRITICAL). THERE HAS BEEN NO MISTREATMENT OR INJURY REPORTED. THE OFFSET CALCULATED BY RTT MAY HAVE A INCORRECT VALUE WHEN A CLIPPED DRR IS USED FOR PT POSITIONING. THE COMPLAINT BEHAVIOR MAY POTENTIALLY RESULT IN A SERIOUS INJURY (DOSE TO WRONG LOCATION) IF THE INCORRECT OFFSET IS APPLIED FOR SEVERAL FRACTIONS. PROBABILITY: D (PROBABLE). THERE HAS BEEN NO MISTREATMENT OR INJURY REPORTED. OUR WORKFLOW RECOMMENDS USING THE CLIPPING FUNCTION FOR DRRS TO ENHANCE THE IMAGE QUALITY DURING FUSION OF THE IMAGES IF REQUIRED. IT IS POSSIBLE TO DETECT THE ISSUE WHEN THE ELECTRONIC RETICLE IS USED TO COMPARE WITH THE BURNED IN RETICLE OF THE DRR. THIS IS AN OPTIONAL WORKFLOW. FINAL CORRECTIVE ACTION IS PENDING FURTHER INVESTIGATION INCLUDING A REVIEW IF OTHER PRODUCTS AT THE CUSTOMER SITE ARE AFFECTED. THE ASSOCIATED RTT ASSOCIATED WITH THE ARTISTE 5238 IS SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    A POTENTIAL PRODUCT ISSUE HAS BEEN REPORTED WITH OUR ARTISTE MV LINEAR ACCELERATOR AND ITS SUBSYSTEM RT THERAPIST (RTT). IN THE ABUNDANCE OF CAUTION THIS ISSUE IS BEING REPORTED. THERE WAS A WRONG OFFSET CALCULATION DURING PT POSITIONING BECAUSE OF MISS-READING CLIPPED DRR IMAGES FROM THE TREATMENT PLANNING SYSTEM. THE CUSTOMER USED A CLIPPING POSSIBILITY IN TREATMENT PLANNING SYSTEM FOR DRR IMAGES AND TRANSFERRED THEM TO THE RTT. AFTER ACQUIRING THE APPROPRIATE PORTAL IMAGE ON THE RTT AND STARTING WITH THE OFFSET CALCULATION, THE RTT DISPLAYED IRRATIONAL HIGH OFFSET VALUES. THE CUSTOMER RECOGNIZED THIS AND DID NOT APPLY THESE OFFSETS TO THE PT. THE CUSTOMER RE-SENT THE DRR IMAGES WITHOUT CLIPPING TO THE RTT AND THE OFFSET CALCULATION WORKED CORRECTLY. IT SEEMS THAT WITH CLIPPING RTT TAKES THE IMAGE CENTER AS THE ISOCENTER. THIS IS RISK SINCE THE OFFSET VALUES MIGHT NOT BE SIGNIFICANT SUCH THAT THE USER WILL RECOGNIZE THE ERROR RESULTING IN THE POSSIBILITY THAT A WRONG OFFSET IS APPLIED AND THE PT COULD BE MISTREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS BRAND NAME: ARTISTE MV ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1