BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAC PINNACLE TREATMENT PLANNING SYSTEM

    MDR report key: 1132925 · Received August 13, 2008

    Report

    Report Number
    1132925
    Event Type
    Injury
    Date Received
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    PHILLIPS MEDICAL SYSTEMS
    Product Code
    MUJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS TO RECEIVE RADIATION THERAPY TO THE TONSILS FOR CANCER. THE PHILLIPS ADAC PINNACLE TREATMENT PLANNING SYSTEM WAS USED. THE SYSTEM APPARENTLY HAS AN AUTOMATIC DEFAULT THAT IS NOT WELL KNOWN. THE DEFAULT OCCURRED WITHOUT THE KNOWLEDGE OF THE PHYSICIAN OR TECHS. THE PATIENT RECEIVED RADIATION TO THE OPTIC NERVES UNINTENTIONALLY FOR A TOTAL OF 31 TIMES. THE PROBLEM WAS DISCOVERED WHEN THE PATIENT PRESENTED WITH A RASH TO AN UNEXPECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAC PINNACLE TREATMENT PLANNING SYSTEM TREATMENT PLANNING SYSTEM, RADIATION ONCOLOGY MUJ PHILLIPS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention| S NO OTHER THERAPIES| NO OTHER THERAPIES