BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 3911513 · Received May 27, 2014

    Report

    Report Number
    1525965-2014-00111
    Date Received
    May 27, 2014
    Report Date
    April 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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

    A PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHILE PERFORMING MAINTENANCE ACTIVITIES, THE "IN" BUTTON ON THE GANTRY CONTROL PANEL WAS STICKING ENGAGED. THE FSE CONFIRMED THERE WAS NO HARM TO A PATIENT, OPERATOR, OR BYSTANDER DUE TO THIS ISSUE. MAINTENANCE ACTIVITIES OCCUR WITH NO PATIENT INVOLVEMENT. THE FSE REPLACED THE RIGHT FRONT AND RIGHT REAR GANTRY CONTROL PANELS TO RESOLVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310472 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1