BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLANCE ICT SP

    MDR report key: 2890920 · Received December 21, 2012

    Report

    Report Number
    1525965-2012-00125
    Date Received
    December 21, 2012
    Report Date
    December 7, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. 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 THAT THE CUSTOMER REPORTED WHILE PERFORMING A PRESCAN FOR A RENAL BIOPSY, THE OPERATOR AND PT DETECTED A BURNING SMELL AND SMOKE COMING OUT OF TOP OF GANTRY. THE SMOKE DETECTOR WENT OFF AND THE PT WAS REMOVED FROM THE TABLE AND THE AREA WAS LOCKED DOWN AND FIRE DEPARTMENT WAS CALLED. THE FIRE DEPARTMENT EVALUATED THE ISSUE AND THERE WAS NO FIRE, ONLY SMOKE. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WAS CALLED TO THE SITE AND EVALUATED THE SYSTEM AND DETERMINED THAT THE ISSUE WAS DUE TO A FAILED UPPER LINEAR INDUCTION MOTOR (LIM MOTOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLANCE ICT SP JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728311

    Patients

    Seq Age Sex Outcome Treatment
    1