BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE BIGBORE ONCOLOGY

    MDR report key: 3251837 · Received July 25, 2013

    Report

    Report Number
    1525965-2013-00204
    Date Received
    July 25, 2013
    Report Date
    June 27, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A F/U MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO WHERE THE CUSTOMER REPORTED THAT THE COUCH WILL NOT ZERO AND THERE IS NO TILTING POSSIBLE WITH THE GANTRY. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND FOUND A REPORT OF A "STUCK BUTTON" IN THE ERROR LOG FILES. THE FSE DETERMINED THAT THE MULTI-FUNCTION FOOTSWITCH HAD MALFUNCTIONED WHICH CAUSED THE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347838 BRILLIANCE BIGBORE ONCOLOGY JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1