BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLANCE 64

    MDR report key: 2933157 · Received January 11, 2013

    Report

    Report Number
    1525965-2013-00007
    Date Received
    January 11, 2013
    Report Date
    December 13, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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 A CUSTOMER WHO REPORTED THAT THE COUCH MOVEMENT BUTTONS ON THE CT GANTRY CONTROL PANEL WERE WORN. THERE HAD NOT BEEN ANY UNCOMMANDED MOTION DURING USE AND NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19536 BRILLANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1