BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICT

    MDR report key: 5002102 · Received August 13, 2015

    Report

    Report Number
    1525965-2015-00220
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Report Date
    July 17, 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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    (B)(4). ON 13-JUL-2015, THE CUSTOMER REPORTED THAT ITERATIVE MODEL RECONSTRUCTION (IMR) CARDIAC IMAGES ACQUIRED UTILIZING THEIR PHILIPS BRILLIANCE ICT SYSTEM, EXHIBITED LOW DENSITY BAND ARTIFACTS WITHIN THE CORONARY VESSELS THAT MIMICKED CARDIOVASCULAR DISEASE. THE CUSTOMER CONFIRMED THAT THERE WERE 5 OCCURRENCES OF THE ARTIFACT. THE FIRST OCCURRENCE TOOK PLACE ON (B)(6) 2015, AND IS DOCUMENTED IN THIS COMPLAINT. THE CUSTOMER CONFIRMED THAT THE FIRST PATIENT'S IMAGES WERE INTERPRETED TO HAVE VESSEL NARROWING, WHICH WAS CONSISTENT WITH THE SYMPTOMS THE PATIENT PRESENTED WITH. THE PATIENT WAS SENT FOR A CARDIAC CATHETER ANGIOGRAPHY (CCA) PROCEDURE BASED ON THE CT IMAGING FINDINGS. THE CCA PROCEDURE WAS COMPLETED WITH NORMAL FINDINGS. THE OTHER OCCURRENCES TOOK PLACE ON 4 CONSECUTIVE PATIENTS ON (B)(6) 2015. THE ARTIFACT WAS RECOGNIZED AND THE PATIENTS DID NOT RECEIVE RESCANS OR CCA PROCEDURES. THE 4 ADDITIONAL OCCURRENCES WERE DOCUMENTED IN SUBSEQUENT COMPLAINT RECORDS. A PHILIPS CLINICAL APPLICATION SPECIALIST (CAS) ATTENDED THE SITE AND EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER. THE CAS RECOMMENDED THAT THE CUSTOMER RAISE THE DOSERIGHT INDEX (DRI) LEVEL FROM 9 TO LEVEL 12 TO REDUCE IMAGE NOISE, AND TO UTILIZE IDOSE RECONSTRUCTIONS IN CONJUNCTION WITH THE IMR RECONSTRUCTIONS FOR CARDIAC PROCEDURES. THE CAS GATHERED THE DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) IMAGES AS WELL AS THE RAW DATA FROM THE PROCEDURES AND SENT THEM FOR EVALUATION BY CT ENGINEERING. 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 CROSS-FUNCTIONAL TEAM OF APPLICATION SPECIALISTS AND APPLICATION SCIENTISTS. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CT CLINICAL PATIENT PROCEDURE, WHILE PERFORMING A CARDIAC CT SCAN UTILIZING ITERATIVE MODEL RECONSTRUCTION (IMR), BANDS OF DECREASED DENSITY AND MOTION ARTIFACTS ACROSS THE DIAMETER OF CORONARY VESSELS WERE DISPLAYED WHEN WORKING UP CORONARY VESSELS USING CURVED MULTI-PLANAR RECONSTRUCTIONS (MPR). THERE WAS NO REPORT OF HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE PHILIPS CLINICAL APPLICATION SPECIALIST (CAS) STATED THAT DOSE RIGHT INDEX WAS INCREASED AND IMR RECONSTRUCTION IS NOW BEING USED IN CONJUNCTION WITH IDOSE IMAGES AS A WORK AROUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CT CLINICAL PATIENT PROCEDURE, WHILE PERFORMING A CARDIAC CT SCAN UTILIZING ITERATIVE MODEL RECONSTRUCTION (IMR), BANDS OF DECREASED DENSITY AND MOTION ARTIFACTS ACROSS THE DIAMETER OF CORONARY VESSELS WERE DISPLAYED WHEN WORKING UP CORONARY VESSELS USING CURVED MULTI-PLANAR RECONSTRUCTIONS (MPR). THERE WAS NO REPORT OF HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE PHILIPS CLINICAL APPLICATION SPECIALIST (CAS) STATED THAT DOSE RIGHT INDEX WAS INCREASED AND IMR RECONSTRUCTION IS NOW BEING USED IN CONJUNCTION WITH IDOSE IMAGES AS A WORK AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536117 ICT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306 .

    Patients

    Seq Age Sex Outcome Treatment
    1