BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRILLIANCE 64 COMPUTED TOMOGRAPHY

    MDR report key: 3433010 · Received October 18, 2013

    Report

    Report Number
    1525965-2013-00347
    Event Type
    Other
    Date Received
    October 18, 2013
    Report Date
    February 23, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PHILIPS APPLICATIONS SPECIALISTS EVALUATED THE IMAGES AND INFORMATION PROVIDED BY THE CUSTOMER AND DETERMINED THAT THE MOST PROBABLE ROOT CAUSE OF THE ARTIFACTS WERE DUE TO COMMON CARDIAC MOTION FROM THE PATIENT. THE SUGGESTED CORRECTIVE ACTION IS TO USE THE GATING TECHNIQUE WHEN PERFORMING CARDIAC SCANS. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM A CUSTOMER SITE THAT THEY ARE SEEING ARTIFACTS ON 20% OF THEIR PATIENTS WHEN PERFORMING THE PULMONARY EMBOLISM (PE) STUDY, AND HAVE CONCERNS FOR THE POTENTIAL MISDIAGNOSE AS A RESULT. THE ARTIFACTS APPEAR ASA DISSECTION OF THE AORTIC VALVE OR AN ANEURYSM IN THE PULMONARY ARTERY. THE CUSTOMER STATED THAT IT USUALLY ONLY SHOWS UP WHEN THE PATIENT HAS A LARGE HEART WITH "WOBBLE". THEY ARE NOT EXPERIENCING ANY OTHER ARTIFACTS ON ANY OTHER STUDIES THAT THEY PERFORM. THE CUSTOMER PROVIDED PHILIPS TWO IMAGES WHERE THE ARTIFACT IS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535427 BRILLIANCE 64 COMPUTED TOMOGRAPHY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1