BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENUITY CT

    MDR report key: 4012742 · Received July 10, 2014

    Report

    Report Number
    1525965-2014-00130
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    January 31, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). ON (B)(6) 2013, DURING FIRST OF A KIND (FOK) PHASE, THE CUSTOMER CONTACTED PHILIPS ENGINEERING VALIDATION LEAD SUPPORT AND REPORTED THAT DURING HEAD CT EXAM (PROTOCOL) SETUP, IN ORDER TO POPULATE PATIENT INFORMATION, THE CUSTOMER (TECHNOLOGIST) USED MOUSE TO CLICK IN THE WORKLIST, THEN USER STARTED ENTERING A PATIENT'S MRN (MEDICAL RECORD NUMBER) IN THE SEARCH FIELD, THE ACCESSION NUMBERS AND PATIENT INFORMATION APPEARED IN THE WORKLIST. THE CUSTOMER THEN USED UP AND DOWN ARROWS ON THE KEYBOARD TO GET TO THE PATIENT OF CHOICE AND SELECTED THE PATIENT NAME USING ENTER'' KEY TO POPULATE PATIENT INFORMATION ON THE CONSOLE (MONITOR). THE CUSTOMER THEN SELECTED THE TABLE ORIENTATION AND THE PROTOCOL AND PERFORMED THE SURVIEW ACQUISITION. AFTER SURVIEW WAS COMPLETED, WHEN THE CUSTOMER WAS PLANNING THE EXAM, THE CUSTOMER NOTICED THAT A DIFFERENT MRN AND PATIENTS NAME WAS ON THE SURVIEW. THE CUSTOMER ENDED THE EXAM TO RESET THE PATIENT WITH THE CORRECT INFORMATION. HOWEVER, THE SURVIEW HAD ALREADY TRANSFERRED TO THEIR PACS (PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM) UNDER THE INCORRECT PATIENTS FILE, DUE TO AUTO TRANSFER SETUP ON THE SYSTEM. THERE WAS NO REPORT OF MISINTERPRETATION, MISTREATMENT, OR RESCAN DUE TO THIS ISSUE. THE CUSTOMER HAD DETERMINED HOW THIS ISSUE CAN BE REPRODUCED AND PROVIDED STEPS ON HOW TO REPRODUCE IN THE ENGINEERING BAY. THE VALIDATION LEAD WAS ABLE TO REPRODUCE THE ISSUE IN HOUSE. THE CHIEF TECHNOLOGIST (CUSTOMER) CONFIRMED THAT THE TWO DIFFERENT PATIENT'S MRN NUMBERS DID NOT HAVE RESEMBLANCE. THE "USE PREVIOUS SURVIEW'' FEATURE WAS FUNCTIONING AS INTENDED ON THE SYSTEM, WHICH ALLOWS CUSTOMER TO USE PREVIOUS SURVIEW SCANNED ON THE SAME PATIENT IF THE TABLE POSITION HAS NOT BEEN CHANGED. THE FSE ALSO EVALUATED THAT THE SYSTEM IS NOT RESPONDING SLOWLY TO HAVE THIS ISSUE CAUSED AT THE CUSTOMER SITE; HE DID NOT FIND ANY DELAY IN RESPONSE OF EACH COMMAND ON THE CONSOLE FOR EXAM CARD SETUP. IN THIS CASE, WHEN THE INCORRECT PATIENT WAS SELECTED THE TECHNOLOGIST HAD NOT VERIFIED THE PATIENT INFORMATION. THE CUSTOMER REITERATED TRAINING TO ALL THE TECHNOLOGIST USING THE SYSTEM TO ENSURE CORRECT PATIENT IS SELECTED BEFORE STARTING THAT PROCEDURE. A BUG REPORT WAS COLLECTED FROM TIME OF OCCURRENCE, PROVIDED TO THE ENGINEERING TEAM FOR FURTHER EVALUATION. THE ENGINEERING TEAM EVALUATED THE LOGFILES AND DETERMINED THAT THIS ISSUE OCCURS WHEN THE OPERATOR MIXES MOUSE CLICKS WITH KEYBOARD NAVIGATION TO SELECT THE PATIENT FROM THE WORK LIST. BASED ON THE INVESTIGATION FOLLOWING CAUSE WAS DETERMINED BY THE ENGINEERING TEAM: THE SOFTWARE HANDLING PATIENT SELECTION FROM THE WORKLIST DID NOT HANDLE THE KEYBOARD PRESSES EVEN THOUGH THE SOFTWARE COMPONENT RESPONSIBLE FOR THE WORKLIST DISPLAY DID GIVE THE IMPRESSION TO THE USER THAT A PATIENT CAN BE PICKED BY KEYBOARD. THEREFORE, WHEN THIS ISSUE OCCURRED AT THE CUSTOMER SITE, THE PATIENT WHO WAS LAST SELECTED BY MOUSE CLICK WAS ALWAYS CHOSEN, DESPITE OF THE PATIENT THAT WAS ACTUALLY MARKED IN THE WORK LIST. A MANDATORY FCO (B)(4) (4.0.1) WAS RELEASED ON 21 MAR 2013 TO ADDRESS THE SOFTWARE DEFECT FOUND IN THE FIELD. THE PRODUCT SAFETY COMMITTEE BINDER (PSC) INCLUDES INFORMATION RELATED THE CORRECTION AND REMOVAL DOCUMENTS FOR THIS ISSUE INCLUDING FSN (B)(4). ON 04/04/2013, (B)(4) WAS INSTALLED ON THE SYSTEM WHICH HAD THE CORRECTION FOR THE REPORTED ISSUE. CAUSE OF EVENT WAS A FAILURE IN THE SOFTWARE CODE. THE SOFTWARE HANDLING PATIENT SELECTION FROM THE WORKLIST DID NOT HANDLE THE KEYBOARD PRESSES EVEN THOUGH THE SOFTWARE COMPONENT RESPONSIBLE FOR THE WORKLIST DISPLAY DID GIVE THE IMPRESSION TO THE USER THAT A PATIENT CAN BE PICKED BY KEYBOARD. THEREFORE, WHEN THIS ISSUE OCCURRED AT THE CUSTOMER SITE, THE PATIENT WHO WAS LAST SELECTED BY MOUSE CLICK WAS ALWAYS CHOSEN, DESPITE OF THE PATIENT THAT WAS ACTUALLY MARKED ON (B)(6) 2013, (B)(4) WAS INSTALLED ON THE SYSTEM WHICH HAD THE CORRECTION FOR THE REPORTED ISSUE. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER TYPING IN A PT'S MRN (MEDICAL RECORD NUMBER) ON THE CT WORKLIST (HIS/RIS) THE TECHNOLOGIST SELECTED THE PT INFO WHICH WAS RETURNED FROM THE HIS/RIS. THE OPERATOR PERFORMED THE SURVIEW SCAN AND RECOGNIZED THAT A DIFFERENT MRN AND PATIENTS NAME WERE ON THE SURVIEW. THE OPERATOR ENDED THE EXAM, BUT THE SURVIEW WENT TO PACS UNDER THE INCORRECT PATIENTS FILE. THERE WAS NO REPORT OF MISINTERPRETATION, MISTREATMENT OR RESCAN DUE TO THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404640 INGENUITY CT JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728326

    Patients

    Seq Age Sex Outcome Treatment
    1