BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICT

    MDR report key: 4932530 · Received July 22, 2015

    Report

    Report Number
    1525965-2015-00204
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    June 24, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2015, (B)(6) REPORTED THAT THE PATIENT HEART RATE (HR) INDICATED ON THEIR PHILIPS BRILLIANCE ICT WAS HIGHER THAN THE PATIENTS ACTUAL HEART RATE. THE CUSTOMER INDICATED THAT DURING A BOLUS TRACKING PROCEDURE AND AFTER PERFORMING THE SURVIEW, THE OPERATOR CHECKED THE PATIENT'S HR INDICATED ON THE GANTRY PANELS. THE HR DISPLAYED ON THE GANTRY PANELS WAS 79 BEATS PER MINUTE (BPM). THE OPERATOR FELT THAT THE PATIENT'S HR WAS TOO HIGH TO ATTAIN THE DESIRED IMAGE QUALITY (IQ) AND ADMINISTERED A BETA BLOCKER TO LOWER THE PATIENT'S HR. AFTER ADMINISTRATION OF THE BETA BLOCKER, THE PATIENTS HR WAS NOT REDUCED. THE OPERATOR ADMINISTERED THE MAXIMUM ALLOWABLE DOSE OF BETA BLOCKER; HOWEVER, THE PATIENT'S HR DID NOT CHANGE. THE OPERATOR CHOSE TO PERFORM THE PROCEDURE WITH THE INDICATED HR OF 79 BPM. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT'S INDICATED HR BEGAN TO LOWER UNTIL IT REACHED 69 BPM. THE CUSTOMER CYCLE POWERED ON THE SYSTEM AND THEN CONTACTED THE PHILIPS HELP DESK FOR ASSISTANCE. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. THE FSE CONNECTED THE ELECTRO CARDIO GRAPH (ECG) TESTER TO EVALUATE THE SYSTEM. THE FSE ALSO EVALUATED THE SYSTEM LOG FILES. THE FSE DETERMINED THAT THE PATIENT'S HR HAD NOT BEEN REFRESHED ON THE SYSTEM SINCE 5 MINUTES BEFORE THE STUDY WAS STARTED. THE FSE FORWARDED THE GATHERED DATA TO ENGINEERING FOR FURTHER EVALUATION. ENGINEERING WAS ABLE TO REPRODUCE THIS DEFECT BY SLOWLY CHANGING THE HEART RATE OVER A PERIOD OF TIME AND NOT SEEING THE HR DISPLAY CHANGE ON THE PANELS. THE ENGINEERING INVESTIGATION FOUND THAT THE CRTC (CARDIAC REAL TIME COMPONENT) HAS A LINE OF SOFTWARE CODE WHERE THE HEART RATE IS NOT UPDATED UNLESS THE AVERAGE HEART RATE FROM THE LAST 3 R-R WAVES IS GREATER THAN +/- 1 BPM FROM THE PREVIOUS AVERAGE. THIS MEANS THAT IF THE AVERAGE HEART RATE CHANGES BETWEEN 1 BPM UP OR 1 BPM DOWN, THE HEART RATE DISPLAY ON THE GPC (GANTRY PERSONAL COMPUTER) AND THE CONSOLE WILL NOT CHANGE. AFTER ENGINEERING PERFORMED SYSTEM TESTING, IT WAS DETERMINED THAT THE FASTEST THE HEART RATE CHANGES WITHOUT IT BEING UPDATED IS ABOUT 12BPM IN 12 SECONDS. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT WHEN THE HR CHANGES VERY SLOWLY, THE DISPLAY WILL NOT BE UPDATED AT THE REQUIRED RATE FOR INFORMATIONAL PURPOSES. THIS FINDING IS FOR THE HR DISPLAY ONLY AND DOES NOT IMPACT CARDIAC PERFORMANCE IN ANY WAY. IT WAS CONFIRMED THAT BY PULLING THE ECG CABLES OFF OR DISCONNECTING THE PATIENT INFORMATION MONITOR (PIM) AND RECONNECTING EVERYTHING, IT WILL CORRECT THIS ISSUE. ALSO, THIS DEFECT DOES NOT AFFECT CARDIAC SCANNING. IT ONLY AFFECTS THE HEART RATE DISPLAY VALUE. THE IFU CARDIAC GUIDE V4 FOR ICT STATES (UNDER ECG VIEWING) THAT THE ECG SHOWN ON THE GANTRY IS NOT TO BE USED FOR DIAGNOSING PATIENT CONDITION. THE CUSTOMER USED THE HEART RATE INFORMATION FOR PURPOSES THAT WERE OUTSIDE OF THE USE SPECIFIED BY THE CARDIAC GUIDE. CT ENGINEERING DETERMINED THIS ISSUE TO BE AN ACCEPTABLE RISK AND IF THE MALFUNCTION WERE TO RECUR IT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY BECAUSE: ¿ WARNING IN THE INSTRUCTION FOR USE THAT THE ECG VIEWER IN THE OPERATOR HOST IS ONLY FOR RECONSTRUCTION PROCESS. THE CRTC (CARDIAC REAL TIME COMPONENT) HAS A LINE OF SOFTWARE CODE WHERE THE HEART RATE IS NOT UPDATED UNLESS THE AVERAGE HEART RATE FROM THE LAST 3 R-R WAVES IS GREATER THAN +/- 1 BPM FROM THE PREVIOUS AVERAGE. THIS MEANS THAT IF THE AVERAGE HEART RATE CHANGES BETWEEN 1 BPM UP OR 1 BPM DOWN, THE HEART RATE DISPLAY ON THE GPC (GANTRY PERSONAL COMPUTER) AND THE CONSOLE WILL NOT CHANGE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING A PATIENT BOLUS TRACKING PROCEDURE, THE HEART RATE (HR) DISPLAY ON THE GANTRY PANEL AND THE SCANNED HR WERE DIFFERENT BY 10 BEATS. THE PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE CONFIRMED THE GANTRY PANEL DISPLAYED A HR OF 79 AND REPORTED THAT THE MAXIMUM DOSAGE OF BETA BLOCKER WAS ADMINISTERED TO THE PATIENT TO REDUCE THE HR, HOWEVER, THE GANTRY PANEL STILL DISPLAYED A HR OF 79. THE FSE STATED THE OPERATOR CHOSE TO COMPLETE THE PATIENT ACQUISITION AND THE RESULTING IMAGES DISPLAYED A HEART RATE OF 69, WHICH WAS A DIFFERENCE OF 10 BEATS THAT WAS DISPLAYED ON THE GANTRY PANEL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING A PATIENT BOLUS TRACKING PROCEDURE, THE HEART RATE (HR) DISPLAY ON THE GANTRY PANEL AND THE SCANNED HR WERE DIFFERENT BY 10 BEATS. THE PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE CONFIRMED THE GANTRY PANEL DISPLAYED A HR OF 79 AND REPORTED THAT THE MAXIMUM DOSAGE OF BETA BLOCKER WAS ADMINISTERED TO THE PATIENT TO REDUCE THE HR, HOWEVER, THE GANTRY PANEL STILL DISPLAYED A HR OF 79. THE FSE STATED THE OPERATOR CHOSE TO COMPLETE THE PATIENT ACQUISITION AND THE RESULTING IMAGES DISPLAYED A HEART RATE OF 69, WHICH WAS A DIFFERENCE OF 10 BEATS THAT WAS DISPLAYED ON THE GANTRY PANEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477582 ICT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306 100079

    Patients

    Seq Age Sex Outcome Treatment
    1