BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICT

    MDR report key: 5014050 · Received August 19, 2015

    Report

    Report Number
    1525965-2015-00227
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Report Date
    July 21, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2015, THE CUSTOMER REPORTED THAT ITERATIVE MODEL RECONSTRUCTION (IMR) CARDIAC IMAGES ACQUIRED UTILIZING THEIR PHILIPS BRILLIANCE ICT SYSTEM, EXHIBITED NON-HOMOGENOUS ARTIFACTS IN THE ARTERIES THAT APPEARED TO BE FILLING DEFECTS. THE CUSTOMER CONFIRMED THAT THE ISSUE OCCURRED THE PREVIOUS DAY ON (B)(6) 2015. THEY REPORTED THAT THE ARTIFACTS WERE NOT VISUALIZED WHEN RECONSTRUCTING THE IMAGES USING IDOSE RECONSTRUCTION TECHNIQUES. THE CUSTOMER CONFIRMED THAT THE ARTIFACTS WERE RECOGNIZED AND THERE WAS NO MISINTERPRETATION OR MISTREATMENT ASSOCIATED WITH THE ISSUE. THE ARTIFACTS DID NOT RESULT IN HARM TO A PATIENT, OPERATOR, OR BYSTANDER. PHILIPS SERVICE GATHERED DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) IMAGES AND RAW DATA DOCUMENTING THE ISSUE AND SENT IT TO THE BUSINESS INNOVATION UNIT (BIU) FOR FURTHER EVALUATION. PHILIPS PHYSICS AND CLINICAL APPLICATIONS GROUPS REVIEWED THE DATA PROVIDED FOR THIS ISSUE AND FOUND: ALL DATA PROVIDED FROM THE ASSOCIATED COMPLAINTS WAS REVIEWED BY RECONSTRUCTING IMAGES WITH IMR AND IDOSE4 USING DIFFERENT SETTINGS. IMAGE REVIEW WAS CONDUCTED WITH A CROSS-FUNCTIONAL TEAM OF APPLICATION SPECIALISTS AND APPLICATION SCIENTISTS. THE FOLLOWING WAS OBSERVED DURING THE IMAGE REVIEWS: USING IMR BODY ROUTINE WAS APPLIED, CORONARY VESSELS WERE NOT ENHANCED. USING IDOSE4 WITH XCB OR CB FILTERS, CORONARY VESSELS WERE NOT ENHANCED. USING IMR CARDIAC ROUTINE, CORONARY VESSELS APPEARED TO BE NON-UNIFORMLY ENHANCED. USING IDOSE4 WITH XCC OR CC FILTER, CORONARY VESSELS APPEARED TO BE NON-UNIFORMLY ENHANCED. THE CAUSE OF THIS NON-UNIFORM CONTRAST ENHANCEMENT IN CORONARY VESSELS WHILE USING IMR CARDIAC ROUTINE AND IDOSE4 WITH XCC OR CC FILTERS IS DUE TO THE FILTER KERNEL WHICH BOOSTS THE CONTRAST IN THE OBJECTS WHICH ARE SIZE OF 2~5 MM. THIS BOOSTING WAS ORIGINALLY DESIGNED FOR A BETTER VISIBILITY OF THE VESSELS AND IS GOOD FOR USE WITH THE AUTOMATIC SEGMENTATION TOOLS. THERE IS NO MALFUNCTION OF THE SYSTEM; THE SYSTEM IS WORKING AS SPECIFIED. THE ARTIFACT CAN BE MINIMIZED USING IMR BODY ROUTINE FILTER OR IDOSE4 WITH XCB OR CB FILTERS WHICH DO NOT INCLUDE LOW FREQUENCY ENHANCEMENT. CT ENGINEERING DETERMINED THIS ISSUE TO BE AN ACCEPTABLE RISK. THE FOLLOWING MITIGATION APPLIES: PHYSICS DESIGN AND ALGORITHM/SPECS, AND QUALITY ASSURANCE WITH TESTING FOR DIFFERENT USERS (CLINICAL AND SERVICE) AND AT VARIOUS TIMES OF INSTALLATION (SERVICE) AND USAGE (CLINICAL) ENSURE THE CORRECT RECON AND POST-PROCESSING. THERE ARE MITIGATIONS IMPLEMENTED IN OUR SYSTEM, AS DESCRIBED ABOVE, TO MINIMIZE THE ARTIFACTS IN THE IMAGES. IN ADDITION, AS WRITTEN IN THE IFU, OPERATORS OF THE CT SYSTEM MUST HAVE RECEIVED OFFICIAL ACCREDITATION OR CERTIFICATE TO OPERATE CT SYSTEM AS WELL AS ADEQUATE TRAINING ON ITS SAFE AND EFFECTIVE USE BEFORE ATTEMPTING TO OPERATE THE EQUIPMENT DESCRIBED IN THE IFU. THIS CAN SIGNIFICANTLY MINIMIZE THE USE ERRORS THAT MIGHT LEAD TO ARTIFACTS.

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING A PATIENT PROCEDURE, USING THE ITERATIVE MODEL RECONSTRUCTION (IMR) ON CORONARY CASES AND HELICAL AND STEP AND SHOOT, AN ARTIFACT WAS OBSERVED IN THE ARTERIES THAT APPEARED LIKE A NON-HOMOGENOUS FILLING DEFECT. THE CUSTOMER REPORTED IF THEY USED IDOSE, THE RECONSTRUCTION IMAGES DID NOT DISPLAY AN ARTIFACT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING A PATIENT PROCEDURE, USING THE ITERATIVE MODEL RECONSTRUCTION (IMR) ON CORONARY CASES AND HELICAL AND STEP AND SHOOT, AN ARTIFACT WAS OBSERVED IN THE ARTERIES THAT APPEARED LIKE A NON-HOMOGENOUS FILLING DEFECT. THE CUSTOMER REPORTED IF THEY USED IDOSE, THE RECONSTRUCTION IMAGES DID NOT DISPLAY AN ARTIFACT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547402 ICT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1