BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCISIVE CT

    MDR report key: 17994080 · Received October 24, 2023

    Report

    Report Number
    3009529630-2023-00018
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    February 21, 2022
    Manufacturer
    PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
    Product Code
    JAK
    UDI-DI
    00884838105508
    PMA / PMN Number
    K212441
    Removal / Correction Number
    Z-1622-2023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT PATIENT POSITION WAS INCORRECTLY RECOGNIZED AS PRONE INSTEAD OF SUPINE. THERE WAS NO PATIENT INJURY OR HARM REPORTED, NO MISDIAGNOSIS HAS OCCURRED. PHILIPS ENGINEERING INVESTIGATION CONCLUDED THAT THE PRELIMINARY CAUSE IS A SOFTWARE ISSUE WHERE THE ALGORITHM MAY FAIL IF THE PATIENT'S APPEARANCE IS BLOCKED/COVERED BY SOMETHING BEYOND CAMERA MONITOR RANGE/CAPABILITY (E.G., THE PATIENT IS PLACED TOO DEEP INTO THE BORE OR COVERED BY SHEET, ETC.).  ADDITIONALLY, ACCORDING TO THE CURRENT DESIGN, THE AUTO CAMERA DETECTION OF PATIENT ORIENTATION WILL OVERLAP THE PRESET PROTOCOL. HOWEVER, THE OPERATOR MAY IGNORE THE CHANGE OF SELECTED PATIENT ORIENTATION. PER THE INSTRUCTIONS FOR USE MANUAL, THE PRECISE POSITION FUNCTION MAY BE AFFECTED BY THE FOLLOWING CONDITIONS: WHEN THE PATIENT IS COVERED BY SHEET, BLANKET ETC., WHEN THE PATIENT IS NOT COMPLETELY COVERED BY THE CEILING CAMERA VIEW, E.G. BLOCKED BY THE GANTRY OR OUT OF CAMERA'S FOV ETC. WHEN THE PATIENT IS WEARING CLOTHES THAT REFLECTS LIGHT, E.G. PLASTIC-LIKE CLOTHES. WHEN THE PATIENT IS WEARING BLACK CLOTHES. WHEN THE PATIENT IS WEARING THICK CLOTHES. WHEN THERE ARE OTHER PEOPLE AROUND THE PATIENT. THE PATIENT ORIENTATION SELECTED IN PATIENT REGISTRATION PAGE AND THE SELECTED PATIENT ORIENTATION ILLUSTRATION DISPLAYED IN PLAN SURVIEW PAGE ARE VISIBLE FOR USER BEFORE THE USER CONFIRMS THE EXAM PROTOCOLS TO START THE SCANNING PROCESS. USERS SHOULD FOLLOW THE GUIDELINES DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU). IT IS VITAL THAT THE USERS ARE AWARE OF THE SYSTEM INSTRUCTIONS AND FUNCTIONALITY, AND TO STRICTLY FOLLOW ALL STEPS DESCRIBED IN THE IFU TO ENSURE THE SAFE OPERATION OF THE DEVICE.   PROBABLE CAUSE: SYSTEM SOFTWARE LIMITATION. CORRECTIVE ACTION: CORRECTION AND REMOVAL HAS BEEN ISSUED TO ALL THE AFFECTED DEVICES.

    Description of Event or Problem · 0

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. IT WAS REPORTED THAT PATIENT POSITION WAS INCORRECTLY RECOGNIZED AS PRONE INSTEAD OF SUPINE. THERE WAS NO PATIENT INJURY OR HARM REPORTED, NO MISDIAGNOSIS HAS OCCURRED. HOWEVER, IIA(ISSUE IMPACT ASSESSMENT) D001255537_REV_C WAS UPDATED WITH RISK ASSESSMENT RE-EVALUATED. AN INTERNAL RETROSPECTIVE REVIEW OF THE COMPLAINT HAS IDENTIFIED THIS COMPLAINT A SIMILAR MALFUNCTION OF A MDR EVENT WE HAVE REPORTED. THEREFORE, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. RISK EVALUATION CONCLUSION IN IIA: POH FOR S0 ¿ MISDIAGNOSIS IS ESTIMATED AT L3 - PROBABLE. POH FOR S1 ¿ MISDIAGNOSIS IS ESTIMATED AT L2 - REMOTE. POH FOR S2 ¿ MISDIAGNOSIS IS ESTIMATED AT L2 - REMOTE. POH FOR S3 ¿ MISDIAGNOSIS IS ESTIMATED AT L2 ¿ REMOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837049 INCISIVE CT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS HEALTHCARE (SUZHOU) CO., LTD. INCISIVE CT 00884838105508

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown