BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 3812335 · Received May 6, 2014

    Report

    Report Number
    1525965-2014-00097
    Date Received
    May 6, 2014
    Report Date
    March 26, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    ON A BRILLIANCE 64 CT SYSTEM AT (B)(6), THE CUSTOMER REPORTED THE MIDDLE PEDAL ON THE MULTIFUNCTION FOOT SWITCH HAD TO BE PRESSED ALL THE WAY DOWN FOR IT TO ACTIVATE. A PHILIPS FIELD SERVICE ENGINEER (FSE) INVESTIGATED AND DETERMINED A BUTTON WAS STUCK ENGAGED ON THE RIGHT REAR GANTRY CONTROL PANEL. THERE WAS NO REPORT OF HARM TO PATIENT, OPERATOR, OR BYSTANDER. THE FSE INSTALLED FOOT PEDAL FIELD CHANGE ORDER (FCO) AND REPLACED THE RIGHT REAR GANTRY CONTROL PANEL TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271808 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1