BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE BIG BORE

    MDR report key: 2458980 · Received February 10, 2012

    Report

    Report Number
    1525965-2012-00003
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Report Date
    January 23, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHILIPS CONCLUDES THAT THE INTENSITY PROJECTION (IP) DATASETS FOR CERTAIN PATIENT ORIENTATION/VIEW CONVENTION COMBINATIONS ARE FLIPPED AND INCORRECTLY LABELED WHEN NON-GATED DATA ALONG WITH GATED SERIES DATE ARE LOADED INTO THE TUMORLOC APPLICATION. THIS ISSUE AFFECTS ONLY THE FOLLOWING PATIENT ORIENTATION/VIEW CONVENTION COMBINATIONS: HEAD FIRST PRONE / RIGHT ON LEFT. FEE FIRST PRONE / VIEW FROM BED. HEAD FIRST PRONE / VIEW FROM FEET. HEAD FIRST PRONE / VIEW FROM BED. FEET FIRST SUPINE / VIEW FROM BED. FEET FIRST PRONE / VIEW FROM FEET. THE AFFECTED PATIENT ORIENTATION/VIEW CONVENTION COMBINATIONS INCLUDE THE FOLLOWING: ADDITIONALLY, PHILIPS HAS DETERMINED THAT THE ROOT CAUSE FOR THIS MALFUNCTION IS A SOFTWARE CODE ERROR AND THAT THERE ARE TWO SCENARIOS THAT CAN RESULT IN HARM TO THE PATIENT. THEY ARE: THE INTENSITY PROJECTION DATASET IS USED TO CREATE OR EDIT CONTOURS AROUND THE TREATMENT AREAS, CRITICAL STRUCTURES ET CETRA USING A NON-TUMORLOC APPLICATION (IF TUMORLOC WAS USED, THE CONTOURS WOULD BE CORRECT). THE CONTOURS THEN DO NOT MATCH THE PHYSICAL ANATOMY. THIS CAN HAPPEN IF THEY CONTOUR ON THE AVERAGE INTENSITY PROJECTION VOLUME AND TREAT USING THE AVERAGE INTENSITY PROJECTION VOLUME OR IF THEY CONTOURED ON A STANDARD DATASET AND CHANGED THEM BECAUSE THEY DID NOT MATCH THE AVERAGE INTENSITY PROJECTION VOLUME DATASET. THE INTENSITY PROJECTION DATASET IS USED BY A DOWNSTREAM APPLICATION TO DIRECTLY PLAN THE TREATMENT. THE TREATMENT PLAN IS CREATED ASSUMING THAT THE ANATOMY IS REPRESENTED PROPERLY. SINCE IT IS NOT, THE INCORRECT ANATOMY IS TREATED. THERE HAS BEEN NO REPORTED INJURY OR DEATH RESULTING FROM THIS PROBLEM, HOWEVER, THERE IS POTENTIAL FOR INJURY BECAUSE THIS ISSUE COULD RESULT IN OVERDOSE TO HEALTHY TISSUE OR UNDER DOSE TO DISEASED TISSUE. THE SOFTWARE CODE ERROR AT THIS SITE WAS FIXED.

    Description of Event or Problem · 1

    THE MEDICAL PHYSICIST AT (B)(6) HOSPITAL REPORTED THAT IF THE FOLLOWING STEPS ARE FOLLOWED, A CLINICAL INTENSITY PROJECTION DATASET CAN BE GENERATED THAT IS FLIPPED FROM LEFT TO RIGHT: ACQUIRE A GATED COMPUTED TOMOGRAPHY DATASET IN HEAD FIRST PRONE OR FEET FIRST SUPINE PATIENT ORIENTATIONS. THE GATED SERIES ARE LOADED ALONG WITH A NON-GATED SERIES INTO TUMORLOC. AN INTENSITY PROJECTION DATASET IS GENERATED AND SAVED TO DISK. THE RESULTING DATASET IS FLIPPED AND LEFT-TO-RIGHT ANNOTATIONS ARE INCORRECTLY LABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE BIG BORE JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1