BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.0M PINNACLE3

    MDR report key: 2992391 · Received March 1, 2013

    Report

    Report Number
    1525965-2013-00030
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    November 2, 2009
    Report Date
    November 2, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    MUJ
    PMA / PMN Number
    K041577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE INVESTIGATION DETERMINED THAT WEDGES SHOULD NOT BE EXPORTED FOR IMRT PLANS AND THE PROBABLE ROOT CAUSE IS A SOFTWARE NONCONFORMANCE. (B)(4).

    Description of Event or Problem · 1

    IMRT PLAN OPTIMIZED IN PINNACLE FOR AN ELECTA LINEAR ACCELERATOR USING WEDGES. WHEN THE PLAN WAS TRANSFERRED TO THE ELEKTA/IMPA MOSAIQ RECORD THE WEDGES WERE SOMEHOW EXCLUDED FROM THE PT TREATMENT. THE PT WAS INCORRECTLY TREATED FOR 4 FRACTIONS BEFORE THIS WAS DISCOVERED AND CORRECTED. PT TREATMENT WAS HALTED AND THE FRACTIONAL DOSE WAS COMPENSATED FOR THE OVER-DOSE IN THE INITIAL 4 FRACTIONS. SYSTEM SERIAL NUMBER IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89100 8.0M PINNACLE3 MUJ PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1