BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE BIG BORE

    MDR report key: 1963696 · Received December 21, 2010

    Report

    Report Number
    1525965-2010-00047
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    May 19, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MDR IS BEING SUBMITTED AS IT IS UNK IF THE SMOKE AND FIRE WAS A RESULT OF A MALFUNCTION OF A COMPONENT INSIDE THE GANTRY. THE INVESTIGATION IS ONGOING. THE NEED FOR THIS MDR WAS IDENTIFIED BY THE RETROSPECTIVE REVIEW OF COMPLAINT (B)(4), FLAGGED BY THE 483 OBSERVATION. THIS REPORT WAS SUBMITTED ON (B)(6) 2010.

    Description of Event or Problem · 1

    PHILIPS REC'D A COMPLAINT THAT ALLEGED THAT ONE OF THE COMPONENTS INSIDE THE GANTRY WAS ON FIRE. THERE WAS ALSO AN ELECTRICAL SMELL AND SMOKE COMING OUT OF THE GANTRY. THERE IS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE BIG BORE JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1