BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENUITY CT

    MDR report key: 4922209 · Received July 17, 2015

    Report

    Report Number
    1525965-2015-00201
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Report Date
    May 18, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2015, THE CUSTOMER, (B)(6), REPORTED THAT DURING A CLINICAL PATIENT PROCEDURE WHILE USING THE UP BUTTON ON THE FRONT RIGHT GANTRY PANEL, THE PATIENT SUPPORT CONTINUED TO MOVE UP EVEN WHEN THE BUTTON WAS RELEASED BY THE OPERATOR. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE OPERATOR PRESSED THE UP BUTTON AGAIN TO STOP THE PATIENT SUPPORT MOTION. THE CUSTOMER CONTACTED THE PHILIPS HELP DESK TO INFORM THEM ABOUT THE EVENT. THE CUSTOMER SUPPORT SPECIALIST (CSS) DISPATCHED A PHILIPS FSE TO THE SITE. THE FSE ARRIVED ON SITE AND EVALUATED THE SYSTEM. THE FSE REVIEWED THE LOG FILES AND FOUND STUCK BUTTON ERRORS. UPON FURTHER EVALUATION, THE FSE DETERMINED THAT THE UP BUTTON ON THE FRONT RIGHT GANTRY CONTROL PANEL WAS STUCK ENGAGED. WHILE AT THE SITE, THE CUSTOMER ALSO INFORMED THE FSE THAT THERE WAS A NOISE COMING OUT FROM THE GANTRY WHEN THE GANTRY ROTATES. THE FSE FOUND THAT THE CABLES FOR THE GANTRY CONTROL PANEL HAD COME LOOSE, WHICH CAUSED THE NOISE. THE FSE REPLACED THE FRONT RIGHT GANTRY CONTROL PANEL AND RE-SECURED THE CABLES PROPERLY TO RESOLVE THE ISSUE. AFTER THE SERVICE, THERE HAVE BEEN NO FURTHER RECURRENCES OF THE EVENT AT THE SITE. THE FSE DID NOT PROVIDE THE LOG FILES/BUG REPORTS AND DEFECTIVE PARTS FOR ENGINEERING ANALYSIS. SINCE THERE WERE NO PARTS RETURNED FROM THE FIELD OR LOG FILES PROVIDED, A ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED BY ENGINEERING; HOWEVER, BASED UPON THE TROUBLESHOOTING SERVICES AND STATEMENTS OF THE FSE, A PROBABLE ROOT CAUSE WAS DETERMINED THAT THE ISSUE OCCURRED DUE TO STUCK BUTTON ON THE FRONT RIGHT GANTRY CONTROL PANEL. THE FSE REPLACED THE GANTRY CONTROL PANEL TO RESOLVE THE ISSUE. ENGINEERING DOCUMENTED THEIR EVALUATION. THE FOLLOWING MITIGATIONS FOR THIS ISSUE INCLUDED FOR UNCOMMANDED MOTION OF THE PATIENT SUPPORT ARE: THE SYSTEM IMPLEMENTS MULTIPLE MEANS TO PREVENT UN-COMMANDED MOTION AND SINGLE POINT OF FAILURE. THESE MEANS INCLUDE WATCHDOG TIMER FOR DRIVE TASKS, REDUNDANT SWITCHES IN THE CONTROL PANEL BUTTONS, COLLISION ENVELOPE AVOIDANCE SOFTWARE, PROVIDING EMERGENCY STOP BUTTONS AND EMERGENCY POWER-OFF (EPO) FOR THE USER IN CASE OF FAILURE OF OTHER DESIGN MITIGATIONS. A FAILURE DURING MOTION COULD BE CAUSED EITHER BY A SOFTWARE DEFECT IN THE EMBEDDED OPERATING SYSTEM USED OR A DEFECT IN THE CONTROL LOGIC IMPLEMENTATION, AND THE SYSTEM WAS UNABLE TO DETECT THAT. THE FAILURE COULD ONLY OCCUR DURING THE TIME WHERE THE OPERATOR INITIATED MOTION VIA THE CONTROL PANEL. IN THIS CASE THE OPERATOR IS IN CONTACT WITH THE PATIENT AND VISUALLY WATCHING THE MOTION AND WOULD SEE THE COUCH CONTINUE TO MOVE AFTER THE BUTTON WAS RELEASED. THE TRAINED OPERATOR WOULD USE THE EMERGENCY STOP CONTROL TO STOP THE MOTION. ALSO, DESIGN MITIGATIONS FOR PREVENTION OF THE HAZARDOUS SITUATIONS INCLUDE: - STOPPING HORIZONTAL MOTION IN THE PRESENCE OF RESISTANCE FORCE (NOT APPLICABLE FOR VERTICAL). - TABLE COLLISION ENVELOPE. - SINGLE FAULT SAFE AGAINST UNCONTROLLED MOTION: - MOTION TASKS WATCHDOG TIMER. IF MAXIMUM TIME OF CONTROL RESPONSE IS EXCEEDED, E-STOP WILL BE ACTIVATED. - DOUBLE SWITCHES ON CONTROL BUTTONS PROVIDES REDUNDANCY SUCH THAT 2 SWITCHES MUST BE ACTIVATED BEFORE A MOTION IS EXECUTED. DESIGN MITIGATIONS ENABLING HUMAN RESPONSE ARE: - CONTINUOUS ACTIVATION FOR MANUAL MOTION. - EMERGENCY STOP CONTROLS ENABLE TERMINATION OF MOTION IN HAZARDOUS CONDITION. - EMERGENCY POWER OFF SWITCH SUPPLIED WITH SYSTEM OR SITE INSTALLATION ENABLES THE. OPERATOR TO SHUT OFF POWER TO THE ENTIRE SYSTEM. - SPEED OF MOTORIZED NON-PROGRAMMED MOTION IS LIMITED. THE FSE REPLACED THE FRONT RIGHT GANTRY CONTROL PANEL AND RE-SECURED THE CABLES PROPERLY, TO RESOLVE THE ISSUE. SINCE THERE WERE NO PARTS RETURNED FROM THE FIELD OR LOG FILES PROVIDED, A ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED BY ENGINEERING; HOWEVER, BASED UPON THE TROUBLESHOOTING SERVICES AND STATEMENTS OF THE FSE, A PROBABLE ROOT CAUSE WAS DETERMINED THAT THE ISSUE OCCURRED DUE TO STUCK BUTTON ON THE FRONT RIGHT GANTRY CONTROL PANEL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GANTRY CONTROL BUTTONS ARE STICKING. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE STATED THAT THE OPERATOR WAS USING A VERTICAL BUTTON AND WHEN THE BUTTON WAS RELEASED, THE COUCH CONTINUED TO MOVE VERTICALLY UNTIL THE OPERATOR PRESSED THE BUTTON AGAIN. THE FSE EVALUATED THE SYSTEM AND DETERMINED THAT THE RIGHT GANTRY CONTROL PANEL HAD FAILED AND REPLACED IT TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466166 INGENUITY CT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1