BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 3233994 · Received July 16, 2013

    Report

    Report Number
    1525965-2013-00197
    Date Received
    July 16, 2013
    Report Date
    June 19, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO FROM THE CUSTOMER REPORTING WHEN PUSHING THE "IN" BUTTON ON THE GANTRY CONTROL PANEL, THE COUCH MOVED UP. THERE WAS NO REPORT OF HARM TO THE PT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329959 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1