BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL SYSTEMS BRILLIANCE 6

    MDR report key: 1427562 · Received April 2, 2009

    Report

    Report Number
    1525965-2009-00012
    Event Type
    Malfunction
    Date Received
    April 2, 2009
    Date of Event
    February 23, 2009
    Report Date
    March 10, 2009
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Removal / Correction Number
    1525962-09/04/07-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    A TEAL POWER DISTRIBUTION UNIT FILTER FAILED, EMITTING SMOKE AND ORDER. THE TEAL UNIT WAS NOT IN THE SAME ROOM AS THE CT SCANNER. NO DEATH OR SERIOUS INJURY HAS OCCURRED AND NO MALFUNCTION HAS OCCURRED WHICH IS LIKELY TO CAUSE A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS BRILLIANCE 6 COMPUTED TOMOGRAPHY SCANNER/JAK JAK PHILIPS HEALTHCARE 728256 NA

    Patients

    Seq Age Sex Outcome Treatment
    1