BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE ICT

    MDR report key: 3020564 · Received March 20, 2013

    Report

    Report Number
    1525965-2013-00057
    Date Received
    March 20, 2013
    Report Date
    February 27, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THAT THE CUSTOMER REPORTED AFTER COMPLETING A PT PROCEDURE AND WHILE REMOVING THE PT FROM THE CT SYSTEM, THE CUSTOMER REPORTED A BURNING SMELL FROM THE CT SYSTEM, THE CUSTOMER REPORTED A BURNING SMELL FROM THE CT GANTRY AND A SMOKE ALARM IN THE CT ROOM WAS ACTIVATED. THE CUSTOMER DID NOT SEE ANY SMOKE OR FIRE, JUST A BURNING SMELL. THE SYSTEM WAS INOPERABLE UNTIL REPAIRED. PHILIPS SERVICE PERSONNEL CONFIRMED THERE WAS NO INDICATION OF SMOKE OR FIRE AND THAT THE FIRE DEPARTMENT WAS NOT CALLED TO THE SITE. THERE WAS NO HARM TO A PT, OPERATOR OR BYSTANDER DUE TO THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115401 BRILLIANCE ICT JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1