BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE BIGBORE ONCOLOGY

    MDR report key: 3020567 · Received March 20, 2013

    Report

    Report Number
    1525965-2013-00055
    Date Received
    March 20, 2013
    Report Date
    February 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INFORMATION THAT THE CUSTOMER WAS ATTEMPTING TO LOWER THE TABLE (COUCH) TO A SAFE POSITION TO UNLOAD THE PT, WHEN THEY RELEASED THE TABLE DOWN BUTTON, THE COUCH CONTINUED TO MOVE IN A DOWNWARD MOTION AFTER THE BUTTON WAS RELEASED. THE COUCH LOWERED TO THE MECHANICAL LOWER LIMIT SWITCH AND WAS ACTIVATED WHICH IN TURN DISABLED ANY COUCH VERTICAL MOVEMENT (SAFETY FEATURE). AT THIS POINT, THE SYSTEM E-STOP WAS ACTIVATED. THERE WAS NO REPORT OF ANY HARM TO A PT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115320 BRILLIANCE BIGBORE ONCOLOGY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1