BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRILLIANCE ICT

    MDR report key: 3432700 · Received September 30, 2013

    Report

    Report Number
    1525965-2013-00308
    Event Type
    Other
    Date Received
    September 30, 2013
    Report Date
    February 9, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO JANUARY OF 2007. THE CUSTOMER PROVIDED IMAGES AND RAW DATA FROM BOTH THE 64 SLICE SCANNER AND THE ICT SCANNER TO PHILIPS FOR REVIEW. THE CUSTOMER REPORTED THAT THEY ARE NOT SEEING THE SAME PE ARTIFACT ON THE BRILLIANCE 64 SLICE CT SCANNER. PHILIPS REVIEWED THE INFO AND DETERMINED THAT A SHARP EDGE APPEARS ON IMAGES WHEN USING THE CARDIAC FILTER AND THAT THERE WAS NO PE ARTIFACT. PHILIPS EVAL CONCLUDED THAT THE REPORTED EVENT WAS LIKELY DUE TO THE CARDIAC FILTERS BEING MISINTERPRETED BY THE USER. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO FROM A CONSUMER SITE THAT THE TECHNOLOGIES ENCOUNTERED A PULMONARY EMBOLUS (PE) ARTIFACT ON A TRI-RULE STUDY FROM THE BRILLIANCE ICT SCANNER. THE CUSTOMER REPORTED THAT THE RESIDENT READ THE STUDY AS HAVING A PE, BUT THE RADIOLOGIST REVIEWED THE STUDY AND DID NOT READ IT AS A PE. THERE WAS NO REPORT OF AN INJURY, MISDIAGNOSIS, OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492658 BRILLIANCE ICT JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1