BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 16 AIR

    MDR report key: 3132765 · Received May 24, 2013

    Report

    Report Number
    1525965-2013-00139
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    April 29, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVLAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. AT THIS TIME, WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER REPORTING THAT DURING MORNING STARTUP, THE GANTRY STARTED, BUT THEN SHUT ITSELF OFF. THE PHILIPS FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE CPM ASSEMBLY HAD FAILED AND WAS PUTTING OFF A BURNING SMELL AND A SMALL AMOUNT OF SMOKE FOR APPROXIMATELY 15 SECONDS. THERE WAS NO FIRE, THE FIRE DEPARTMENT WAS NOT CALLED AND NO FIRE/SMOKE ALARMS WERE ACTIVATED. THERE WAS NO PT INVOLVEMENT DURING THE START-UP OF THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232719 BRILLIANCE 16 AIR JAK PHILIPS MEDICAL SYSTEMS (CLEVLAND), INC. 728246

    Patients

    Seq Age Sex Outcome Treatment
    1