BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 16 WATER

    MDR report key: 3234000 · Received July 16, 2013

    Report

    Report Number
    1525965-2013-00198
    Date Received
    July 16, 2013
    Report Date
    June 19, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 A REPORT WHERE A CUSTOMER WENT TO LOWER THE TABLE USING THE GANTRY PANEL BUTTON THE BUTTON STUCK AND THE TABLE MOVED ALL THE WAY DOWN TO THE LOWEST LIMIT. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THERE WAS NO HARM TO A PT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329961 BRILLIANCE 16 WATER JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728245

    Patients

    Seq Age Sex Outcome Treatment
    1