BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRILLIANCE BIG BORE ONCOLOGY

    MDR report key: 3432701 · Received September 30, 2013

    Report

    Report Number
    1525965-2013-00307
    Event Type
    Other
    Date Received
    September 30, 2013
    Report Date
    August 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO (B)(4) 2007. PHILIPS WAS PROVIDED THE PLAN AND TRANSCRIPTS BY THE CUSTOMER. FROM THE TRANSCRIPTS, IT WAS LEARNED THAT NO ISOCENTER WAS IMPORTED FROM LOC FOR THE PT IN QUESTION. IT WAS DETERMINED THE TREATMENT ISOCENTER DID EXIST IN LOC AT THE CORRECT LOCATION. THE ISOCENTER USED FOR THE TREATMENT WAS CREATED WHEN A BEAM WAS ADDED, THIS ACTION ADDS A DEFAULT ISOCENTER AT THE CENTER OF THE SCAN VOLUME IF NONE EXISTS. THE CUSTOMER THEN CHANGED THE NAME OF THE ISOCENTER TO THE ONE USED IN THE PLAN. THE INSTRUCTIONS FOR USE (IFU) DOCUMENTS HAVE BEEN REVIEWED WITH THE SITE AND FURTHER TRAINING WAS OFFERED TO EMPLOYEE. PHILIPS REVIEWED THE IFUS AND CONCLUDED THAT THE DIRECTIONS ARE CLEAR FOR COMPLETING THE TRANSFER OF DATA FROM TUMOR LOC TO PINNACLE. COMPLAINT PR# (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO FROM A CUSTOMER SITE THAT THE INCORRECT ISOCENTER WAS USED IN A PT TREATMENT. THE CUSTOMER REPORTED THAT THEY CREATED A TREATMENT ISOCENTER IN LOC FOR A WHOLE BRAIN TREATMENT. NO INFO WAS REPORTED FROM LOC AT THAT TIME BECAUSE THE PT SET UP WAS MANUAL. HOWEVER, WHEN A BOOST BRAIN TREATMENT WAS PERFORMED THE CUSTOMER CLAIMS THAT THE ISOCENTER WAS SENT FROM LOC TO PINNACLE, AND IMPORTED INTO THE PT STUDY AND USED FOR THE BOOST PLAN. PORT FILMS WERE TAKEN BEFORE TREATMENT, BUT THEY WERE NOT CHECKED UNTIL AFTER THE FIRST BOOST TREATMENT. THE CUSTOMER DISCOVERED THE ERROR AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492855 BRILLIANCE BIG BORE ONCOLOGY JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1