BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 3040174 · Received April 3, 2013

    Report

    Report Number
    1525965-2013-00075
    Date Received
    April 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM THE CUSTOMER REPORTING AFTER THE PT WAS MOVED ONTO THE CT COUCH, THE OPERATOR WAS CENTERING (HORIZONTALLY AND VERTICALLY) THE PT ON THE COUCH FOR A CT PROCEDURE WHEN THE COUCH DROPPED A COUPLE OF INCHES DOWNWARD WHICH CAUSED THE SYSTEM TO OPEN THE ESTOP. THERE WAS NO HARM TO THE PT OR OPERATOR AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137050 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1