BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 3121622 · Received May 16, 2013

    Report

    Report Number
    1525965-2013-00123
    Date Received
    May 16, 2013
    Report Date
    April 19, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE WILL FILE A F/U MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4). INITIAL MDR MAILED ON (B)(4) 2013.

    Description of Event or Problem · 1

    PHILIPS REC'D INFO FROM THE CUSTOMER REPORTING WHEN PERFORMING A SHORT TUBE CONDITIONING (TC) ON THE CT SYSTEM WHITE SMOKE AND A BURNING SMELL COMING FROM THE GANTRY. THERE WAS NO PT INVOLVEMENT. THERE WAS NO REPORT OF HARM TO A PT, OPERATOR, OR BYSTANDER DUE TO THIS ISSUE. PHILIPS SERVICE CONFIRMED THERE WAS NO PT INVOLVEMENT. THERE WAS NO REPORT OF HARM TO A PT, OPERATOR, OR BYSTANDER DUE TO THIS ISSUE. PHILIPS SERVICE CONFIRMED THERE WAS ONLY SMOKE AND A BURNING SMELL, THERE WAS NO FIRE OR INDICATION OF FIRE AND THE FIRE DEPARTMENT WAS NOT CALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216528 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1