BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRILLIANCE 64

    MDR report key: 4131168 · Received August 25, 2014

    Report

    Report Number
    1525965-2014-00151
    Event Type
    Death
    Date Received
    August 25, 2014
    Report Date
    August 15, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE CUSTOMER REPORTED THAT THE PATIENT SUPPORT OF THEIR BRILLIANCE 64 SLICE CT SYSTEM WOULD NOT MOVE VERTICALLY AS REQUESTED DURING AN EMERGENCY MEDICAL SITUATION. PHILIPS BECAME AWARE OF THE ISSUE ON (B)(4) 2014, BUT THE MALFUNCTION OCCURRED ON (B)(6) 2014. THE CUSTOMER REPORTED THAT A PATIENT WAS BEING SCANNED FOR A CT AORTA PROCEDURE WHEN THE PATIENT'S CONDITION BEGAN TO WORSEN. THE TRAINED PROFESSIONAL DETERMINED THAT THE PATIENT REQUIRED FIRST AID AND BEGAN MOVING THE PATIENT SUPPORT OUT OF THE GANTRY UTILIZING THE MULTI-FUNCTION FOOT SWITCH (MFFS). ONCE THE PATIENT WAS OUT OF THE GANTRY, THE CUSTOMER ATTEMPTED TO LOWER THE PATIENT SUPPORT UTILIZING THE MFFS SO THAT CARDIOPULMONARY RESUSCITATION (CPR) COULD BE INITIATED. THE PATIENT SUPPORT WOULD NOT LOWER WHEN COMMANDED TO DO SO BY THE MFFS. THE CUSTOMER ATTEMPTED TO LOWER THE PATIENT SUPPORT WITH THE GANTRY CONTROL PANEL CONTROLS, BUT THE PATIENT SUPPORT WOULD STILL NOT LOWER. CPR WAS PERFORMED BY THE HOSPITAL STAFF WITH THE PATIENT STILL ON THE CT SYSTEM. THE PATIENT SUCCUMBED TO A PRE-EXISTING CONDITION. THE CUSTOMER WAS ABLE TO RESTORE NORMAL FUNCTION OF THE PATIENT SUPPORT AND DID NOT CONTACT PHILIPS SERVICE REGARDING THE ISSUE UNTIL 2 DAYS LATER ON (B)(4) 2014. A HOSPITAL INCIDENT REPORT WAS FILED, BUT WAS NOT PROVIDED TO PHILIPS UPON REQUEST. ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE CUSTOMER SITE AND EVALUATED THE SYSTEM. THE FSE CONFIRMED THAT ALTHOUGH THE CT SYSTEM MALFUNCTIONED, THE PATIENT EXPIRED DUE TO PRE-EXISTING CONDITIONS AND NOT DUE TO THE MALFUNCTION OF THE SYSTEM. THE FSE PERFORMED FUNCTIONAL TESTING OF THE SYSTEM IN AN ATTEMPT TO REPRODUCE THE MALFUNCTION. . THE FSE CONFIRMED THAT THE CALIBRATION VALUES FOR THE HEIGHT AND POSITION OF THE PATIENT SUPPORT WERE CORRECT. THE FSE WAS UNABLE TO REPRODUCE THE MALFUNCTION ALLEGED BY THE CUSTOMER DURING FUNCTIONAL TESTING OF THE SYSTEM. THE FSE REVIEWED THE SYSTEM ERROR LOGS AND FOUND "S_MC_DEVICE_COUCH_VERTICAL_HW_FAULT" ERRORS LISTED. THROUGH ERROR LOG ANALYSIS, THE FSE DETERMINED THAT THE COUCH POWER BOARD, VERTICAL LIMIT BRAKE CABLE, AND SAFETY BAR BRACKET LIMIT SWITCH HAD FAILED. THE FSE ORDERED REPLACEMENTS FOR THE FAILED PARTS. ON (B)(4) 2014, THE FSE RETURNED TO THE CUSTOMER SITE AND REPLACED THE COUCH POWER BOARD, VERTICAL LIMIT BRAKE CABLE, AND SAFETY BAR BRACKET LIMIT SWITCH TO RESOLVE THE ISSUE. THE FAILED PARTS AND SYSTEM ERROR LOG FILES WERE SENT FOR ANALYSIS BY CT ENGINEERING. THE FSE REPAIR ACTIONS WERE DOCUMENTED IN AN SAP SERVICE WORK ORDER.. THE ERROR LOG FILES FROM THE EVENT WERE REVIEWED AND THE FOLLOWING ERROR CODES WERE SEEN (CONFIRMING THE CUSTOMER'S ALLEGATION OF MALFUNCTION): "S_MC_DEVICE_SOFT_LIMIT_ON." "S_MC_DEVICE_COUCH_VERTICAL_HW_FAULT." THE RETURNED PARTS WERE EVALUATED BY CT ENGINEERING. FUNCTIONAL TESTING WAS PERFORMED UTILIZING A SIMULATOR AS WELL AS INSTALLING THE PARTS ON A WORKING SYSTEM. CT ENGINEERING WAS UNABLE TO REPRODUCE THE MALFUNCTION ALLEGED BY THE CUSTOMER. THE RETURNED PARTS WERE DETERMINED TO BE WORKING AS SPECIFIED. CT ENGINEERING LISTED TWO POTENTIAL CAUSES OF THE MALFUNCTION: THE SAFETY BAR BRACKET LIMIT SWITCH CABLE WAS NOT CONNECTED WELL WITH THE SWITCH. THE VERTICAL LIMIT BRAKE CABLE WAS NOT CONNECTED WELL WITH THE BRAKE. CT ENGINEERING INVESTIGATED THE ISSUE AND DETERMINED THAT THERE IS NO HAZARD IDENTIFIED FOR THIS ISSUE. ENGINEERING STATED THAT THERE IS NO INHERENT RISK IN THE PATIENT SUPPORT NOT BEING ABLE TO BE LOWERED. ENGINEERING AND CLINICAL APPLICATION CONFIRMED THAT IF THE PATIENT SUPPORT IS UNABLE TO MOVE VERTICALLY DOWNWARDS, THE PATIENT IS STILL ACCESSIBLE TO THE RADIOLOGIST AND PHYSICIANS IN MEDICAL EMERGENCIES. WITH REGARDS TO THE LOGS, THE ANALYSIS SHOWS THAT THE SAFETY BAR SWITCH OPENED WHICH COULD HAVE BEEN CAUSED BY A DEFECTIVE SWITCH OR THE CABLE CONNECTING THE SWITCH TO THE PCB. THIS SWITCH IS IN SERIES WITH THE LOWER SOFT LIMIT SWITCH; HENCE, IT LOOKS LIKE THE LOWER SOFT LIMIT WAS REACHED WHERE IT REALLY WAS NOT, WHICH PREVENTED FURTHER DOWNWARDS MOTION OF PATIENT SUPPORT. THE FSE EXCHANGED THE SAFETY BAR SWITCH, SOFT LIMIT SWITCH AND THE CABLE CONNECTING THE SAFETY BAR SWITCH WHICH CORRECTED THE PROBLEM. THE FSE REPLACED THE COUCH POWER BOARD, VERTICAL LIMIT BRAKE CABLE, AND SAFETY BAR BRACKET LIMIT SWITCH TO RESOLVE THE ISSUE. THE PATIENT EXPIRED DUE TO PRE-EXISTING CONDITIONS. SINCE THERE WERE MULTIPLE PARTS REPLACED AND ENGINEERING WAS UNABLE TO REPRODUCE THE ISSUE, A ROOT CAUSE COULD NOT BE DETERMINED BY ENGINEERING. BASED ON THE EVALUATION OF THE LOG FILES AND THE DEFECTIVE PARTS, THE PROBABLE CAUSES OF THE ISSUE WITH COUCH MOTION WERE DETERMINED TO BE: THE SAFETY BAR BRACKET LIMIT SWITCH CABLE WAS NOT CONNECTED WELL WITH THE SWITCH. THE VERTICAL LIMIT BRAKE CABLE WAS NOT CONNECTED WELL WITH THE BRAKE.

    Additional Manufacturer Narrative · 1

    CLARIFYING FSE STATED THAT THE MEDICAL OPERATORS WHO WERE WORKING ON THE PATIENT CONFIRMED THAT THE PATIENT EXPIRED DUE TO THE PRE-EXISTING CONDITIONS AND NOT DUE TO MALFUNCTION OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE FOR A PT WITH A PREEXISTING CONDITION OF A TORN AORTA, THE PT TABLE WOULD NOT MOVE DOWN WHEN PRESSING THE FOOTSWITCH (UNLOAD PEDAL). THE CUSTOMER ALLEGED THAT THERE WAS A DELAY IN PERFORMING FIRST AID (CPR) TO THE PT WHEN NEEDED. THE CUSTOMER REPORTED THAT THE PT EXPIRED. PHILIPS SERVICE EVALUATED THE LOGFILES AND FOUND THAT A S_MC_DEVICE_COUCH_VERTICAL_HW_FAULT HAD OCCURRED. PHILIPS SERVICE REPLACED THE COUCH POWER BOARD ASSEMBLY, SAFETY BAR SWITCH AND COUCH VERTICAL LIMITS/BRAKE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513948 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC 728231

    Patients

    Seq Age Sex Outcome Treatment
    1 Death