BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLANCE 64

    MDR report key: 3841302 · Received May 20, 2014

    Report

    Report Number
    1525965-2014-00108
    Date Received
    May 20, 2014
    Report Date
    April 23, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    THE CUSTOMER REPORTED THAT DURING THE POSITIONING OF A PT THE COUCH MOVED OUT WHEN THE CUSTOMER ENGAGED THE "LOAD" FUNCTION FROM THE MULTI-FUNCTIONAL FOOTSWITCH AND CONTROL PANEL. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THERE WAS NO HARM TO A PT, BYSTANDER, OR OPERATOR. THE CUSTOMER REBOOTED THE SYSTEM TO RESOLVE THE ISSUE. THE FSE FOUND THAT AN ERROR IN THE BUG REPORT REPORTED THAT THE "HORIZONTAL OUT" BUTTON WAS STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299143 BRILLANCE 64 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1