BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRILLIANCE 16 AIR COMPUTED TOMOGRAPHY

    MDR report key: 3405777 · Received September 17, 2013

    Report

    Report Number
    1525965-2013-00265
    Event Type
    Other
    Date Received
    September 17, 2013
    Date of Event
    September 11, 2009
    Report Date
    September 11, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO (B)(4) OF 2007. THE FIELD SERVICE ENGINEER EVALUATED THE SYSTEM REGARDING THE REPORTED EVENT AND DETERMINED THE REPORTED ARTIFACTS WERE DUE TO THE CUSTOMER SITE NOT PERFORMING ROUTINE AIR CALIBRATIONS ON THE SYSTEM IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, BRILLIANCE CT VOLUME 1, PART # 453567473691 A, SECTIONS 4.4 AND 7.3. THE FSE PERFORMED AIR CALIBRATIONS WHICH RESOLVED THE ARTIFACTS.(B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER SITE WHERE TWO PATIENTS WERE SCANNED ON A BRILLIANCE 16 AIR TO ACQUIRE HEAD STUDIES. THE ACQUIRED IMAGE ON BOTH HEAD STUDIES - ONE PERFORMED WITH CONTRAST, ONE WITHOUT CONTRAST - DISPLAYED AN IMAGE ARTIFACT. THE RADIOLOGIST ALLEGES TO HAVE NEARLY MISDIAGNOSED THE ARTIFACT AS A TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468971 BRILLIANCE 16 AIR COMPUTED TOMOGRAPHY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728246

    Patients

    Seq Age Sex Outcome Treatment
    1