BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENUITY CORE128

    MDR report key: 5055876 · Received September 4, 2015

    Report

    Report Number
    1525965-2015-00239
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Report Date
    August 12, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015, THE CUSTOMER REPORTED THAT DURING THE UNLOADING OF A PATIENT ON THEIR INGENUITY CORE 128 SYSTEM, AFTER THE PROCEDURE HAD COMPLETED SUCCESSFULLY, THE PATIENT SUPPORT MOVED DOWN BY ITSELF. A PHILIPS SERVICE ENGINEER (PSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE CUSTOMER POWERED DOWN THE SYSTEM UNTIL PHILIPS SERVICE ENGINEER (PSE) WAS ABLE TO INVESTIGATE THE ISSUE. AFTER INVESTIGATION BY THE PSE, IT WAS DETERMINED THAT THE PATIENT SUPPORT¿S VERTICAL BRAKE HAD FAILED AND WAS REPLACED BY THE PHILIPS SERVICE ENGINEER. THE DEFECTIVE VERTICAL BRAKE AND SYSTEM LOG FILES WERE PROVIDE TO PHILIPS ENGINEERING FOR EVALUATION. IT WAS CONFIRMED BY THE PSE THAT THE PATIENT SUPPORT WAS REPLACED WITH A NEW ASSEMBLY ON 29-SEP-2015. PHILIPS ENGINEERING INVESTIGATED AND DETERMINED THAT THE VERTICAL BRAKE MOTOR TYPE INVOLVED WITH THIS EVENT WAS A 20:1 ROTATION. THE LOG FILES WERE REVIEWED AND DETERMINED THAT THE COUCH STARTED TO MOVE DOWN AT ABOUT 160MM DISTANCE, WHICH WAS APPROXIMATELY 10 SECONDS OF TIME. THERE WAS NO SUDDEN DROP OF THE COUCH. THE DEFECTIVE PART WAS ANALYZED AND WAS DETERMINED THAT THE FRACTURE OF THE SPLINE OCCURRED DUE TO MECHANICAL OVERLOAD DAMAGE RESULTING IN CRACK INITIATION AT THE CORNER OF A KEYWAY THAT LINKED THE SPLINE TO THE SHAFT OF THE MOTOR ASSEMBLY. THE OVERLOAD FRACTURE APPEARED TO BE CAUSED BY AN UPSET LOADING CONDITION WHERE EXCESSIVE FORCE HAS BEEN APPLIED TO THE SPLINE WHEN THE KEY WAS PULLED UP BY ELECTRIC MAGNETIC FORCE. THE KEY WAS LOOSE DUE TO THE LACK OF LOCTITE 603 WHEN THE COUCH WAS BUILT. CT ENGINEERING DETERMINED THIS ISSUE TO BE AN ACCEPTABLE RISK AND THE FOLLOWING RISK MITIGATIONS APPLY: *WHEN REQUESTED TO MOVE THE TABLE BY THE OPERATOR, THE SYSTEM SHALL MOVE THE TABLE HORIZONTALLY ACCORDING TO THE REQUESTED MOTION IN THE FOLLOWING SPEEDS: HORIZONTAL IN/OUT ¿ SLOW 25 [MM/SEC] HORIZONTAL IN/OUT ¿ FAST LESS THAN OR EQUAL TO 185 [MM/SEC] LOAD/UNLOAD 185 [MM/SEC] MOVE TO INNER/OUTER LASER 100 [MM/SEC] *WHEN THE OPERATOR REQUESTS TO MOVE THE TABLE VERTICALLY BY LOAD/UNLOAD/UP/DOWN OPERATIONS, THE SYSTEM SHALL BE ABLE TO COMPLETE THE MOTION IN THE RANGE OF FULL-DOWN TO ISO-CENTER POSITION, WITHIN 30 SECONDS. *THE SYSTEM SHALL PROVIDE FREE-FLOAT HORIZONTAL MOTION MODE TO THE COUCH, ALLOWING THE USER TO MOVE THE COUCH CARBON-TOP, BY USING A SWITCH AT THE COUCH HANDLE TO ENGAGE AND WITH FORCE OF NO MORE THAN 67N WHEN THE COUCH IS NOT LOADED. *WHILE THE COUCH IS IN MOTORIZED MOTION, IF THE FREE-FLOAT WAS ACTIVATED BY THE USER, THE SYSTEM SHALL ABORT THE MOTORIZED MOTION WITHIN 1 SECOND FROM THE FREE-FLOAT ACTIVATION TIME. FOR THE RANGE OF THE PATIENT LOAD, IF A RESISTANCE FORCE EQUAL TO OR GREATER THAN THE VALUE LISTED IN THE TABLE BELOW IS DETECTED DURING COUCH HORIZONTAL MOTION, THE SYSTEM SHALL ABORT THE MOTION: COUCH CONFIGURATION FORCE APPLIED - BARIATRIC COUCH 31.75 KGF (70 POUNDS FORCE) EXTENDED COUCH 31.75 KGF (70 POUNDS FORCE) STANDARD COUCH 18.14 KGF (40 POUNDS FORCE) BEDROCK COUCH 36.29 KGF (80 POUNDS FORCE). *WHILE THE COUCH IS EXECUTING A CONTROLLED MOTION, IF THE ACTUAL HORIZONTAL POSITION DIFFERS BY MORE THAN 25MM FROM THE COMMANDED POSITION, THEN THE SYSTEM SHALL STOP THE COUCH MOTION. *THE SYSTEM SHALL PROVIDE AT LEAST ONE OF THE FOLLOWING MEASURES FOR TRAPPING ZONES: GAPS IN ACCORDANCE AS SPECIFIED IN IEC 60601-1, ED. 3.0, CLAUSE 9.2.2.2 SAFE DISTANCES AS SPECIFIED IN IEC 60601-1, ED. CLAUSE 9.2.2.3 GUARDS AND PROTECTIVE MEASURES AS SPECIFIED IN IEC 60601-1, ED. 3.0, CLAUSE 9.2.2.4 CONTINUOUS ACTIVATION AS SPECIFIED IN IEC 60601-1, ED. 3.0, CLAUSE 9.2.2.5 THE SYSTEM SHALL BE SINGLE FAULT SAFE AGAINST UNCONTROLLED MOTION IN ACCORDANCE WITH IEC 60601-2-44, CL. 201.9.2.3.1. ED. 3.0. THE SYSTEM SHALL CONTAIN EMERGENCY ACTUATORS LOCATED AT THE FRONT AND REAR CONTROL PANELS OF THE GANTRY, INSIDE THE GANTRY FRONT COVER ACCESSIBLE WHEN THE FRONT COVER IS OPEN, AT THE OPERATOR CONTROL BOX IN THE CONTROL ROOM, WHICH SHALL PROVIDE EMERGENCY STOPPING OF RADIATION OUTPUT AND MOTION IN ACCORDANCE WITH ALL THE REQUIREMENTS OF IEC 60601-1, ED. 3.0, CLAUSE 9.2.4 AND IEC 60601-1, ED. 2.2, CLAUSE 22.7. FOR COUCH SPEEDS UP TO 250MM PER SECOND WHEN THE EMERGENCY STOP IS ACTUATED THE SYSTEM SHALL INITIATE ACTION TO STOP THE PATIENT SUPPORT AND GANTRY LINEAR MOTION IN THE Z DIRECTION WITHIN 10 MILLIMETERS OF TRAVEL AND SHALL STOP WITHIN 25 MILLIMETERS AFTER ACTUATION OF THE EMERGENCY STOP IN ACCORDANCE WITH IEC 60601-2-44, ED. 3.0 CL. 201.9.2.4. THE SYSTEM EMERGENCY STOP DEVICES, ONCE ACTUATED, SHALL MAINTAIN THE SYSTEM IN THE DISABLED CONDITION UNTIL A DELIBERATE ACTION, DIFFERENT FROM THAT USED TO ACTUATE IT, IS PERFORMED IN ACCORDANCE WITH IEC60601-1 ED 3.0 CLAUSE 9.2.4J. THE SYSTEM OR ITS PARTS SHALL HAVE ADEQUATE MECHANICAL STRENGTH AND SHALL NOT RESULT IN AN UNACCEPTABLE RISK DUE TO MOLDING STRESS OR WHEN SUBJECTED TO MECHANICAL STRESS CAUSED BY PUSHING, IMPACT, DROPPING AND ROUGH HANDLING IN ACCORDANCE WITH IEC 60601-1, ED. 3.0, CLAUSE 15.3 AND IEC 60601-1, ED. 2.2, CLAUSE 54.1. THE SYSTEM ENCLOSURES SHALL HAVE SUFFICIENT RIGIDITY TO WITHSTAND A STEADY FORCE OF 250N+/- 10N APPLIED FOR A PERIOD OF 5 SECONDS APPLIED BY A TOOL HAVING A CIRCULAR PLANE SURFACE OF 30MM IN DIAMETER IN ACCORDANCE WITH IEC 60601-1, ED. 3.0, CLAUSE 15.3.2 AND IEC 60601-1, ED. 2.2, CLAUSE 21A. THE SYSTEM HANDHELD PARTS SHALL HAVE THE ABILITY TO WITHSTAND A FREE FALL WITHOUT INTRODUCING AN UNACCEPTABLE RISK WHEN DROPPED FROM A HEIGHT OF THE NORMAL USE OR 1 METER WHICHEVER IS GREATER ONTO A SURFACE AS SPECIFIED IN ACCORDANCE WITH IEC 60601-1, ED. 3.0, CLAUSE 15.3.4 AND IEC 60601-1, ED. 2.2, CLAUSE 21.5. THE SYSTEM ENCLOSURES CONSTRUCTED OF MOLDED OR FORMED THERMOPLASTIC MATERIALS SHALL BE CONSTRUCTED SUCH THAT ANY SHRINKAGE OR DISTORTION OF THE MATERIAL DUE TO RELEASE OF INTERNAL STRESSES CAUSED BY THE MOLDING OR FORMING OPERATION DOES NOT RESULT IN AN UNACCEPTABLE RISK IN ACCORDANCE WITH IEC 60601-1, ED. 3.0, CLAUSE 15.3.6 THE SELECTION AND TREATMENT OF MATERIALS SHALL TAKE INTO ACCOUNT OF THE INTENDED USE , THE EXPECTED SERVICE LIFE AND THE CONDITIONS FOR TRANSPORT AND STORAGE IN ACCORDANCE WITH IEC 60601-1, ED. 3.0, CLAUSE 15.3.7 AND IEC 60601-1, ED. 2.2, CLAUSE 55.2. USING A PHANTOM WITH MARKERS ALIGNED TO THE HORIZONTAL AND VERTICAL PLANE THE DEVIATION OF THE MARKER FROM THE VERTICAL OR HORIZONTAL REFERENCE SHALL BE LESS THAN 3 MM OVER A DISTANCE OF 20 CM., IN ACCORDANCE WITH IEC60601-2-44, ED 3.1, CL. 201.101.8.3 THE SERVICE MANUAL SHALL HAVE INSTRUCTIONS ON HOW TO DE-ENERGIZE THE SYSTEM BY USING THE SERVICE SWITCH OR EMERGENCY POWER OFF SWITCH WHEN INITIATING A GANTRY TILT MOTION, THE SYSTEM SHALL VERIFY THE COMMANDED MOTION IS EXECUTED IN THE REQUESTED DIRECTION AND STOP THE MOTION IN CASE THE SYSTEM IDENTIFIES OPPOSITE DIRECTION MOTION. THE SYSTEM SHALL REQUIRE A CONTINUOUS ACTIVATION BY THE OPERATOR FOR ALL OPERATOR HARDWARE CONTROL THAT ACTUATES A MOTION OF COUCH, WITH THE EXCEPTION OF A PROGRAMED SCAN SEQUENCE. THE SYSTEM SHALL REQUIRE A CONTINUOUS ACTIVATION BY THE OPERATOR FOR ALL OPERATOR HARDWARE CONTROLS THAT ACTUATE A MOTION OF GANTRY TILT. WHEN THE REQUESTED HORIZONTAL MOVE IS MORE THAN 100MM FROM THE CURRENT TABLE POSITION, AND IF A MINIMUM OF ONE OF THE FOLLOWING ARE TRUE: 1) THE SCAN WAS NOT PLANNED ON A SURVIEW. 2) THE SCAN WAS PLANNED ON A SURVIEW BUT EXCEEDS THE SURVIEW BOUNDARIES BY MORE THAN 100MM IN THE IN DIRECTION. 3) THE COUCH HEIGHT WAS CHANGED BY MORE THAN 10MM RELATIVE TO THE LAST SURVIEW SCAN. 4) THE SCAN WAS PLANNED WITH A CHANGE TO THE GANTRY TILT IF APPLICABLE (I.E. WHEN TILT MOVEMENT IS REQUIRED AS PART OF GETTING READY) THEN THE OPERATOR SHALL BE REQUIRED TO PRESS AND HOLD THE ENABLE BUTTON TO ALLOW MOVEMENT. THE SYSTEM SHALL PROVIDE AN EMERGENCY POWER CUTOFF CONTROL THAT TERMINATES THE POWER SUPPLY TO THE SYSTEM. THE PHILIPS FSE REPLACED THE PATIENT COUCH ON 29-SEP-2015. BASED UPON ENGINEERING'S INVESTIGATION, THE CAUSE WAS DETERMINED THAT THE FRACTURE OF THE SPLINE OCCURRED DUE TO MECHANICAL OVERLOAD DAMAGE RESULTING IN CRACK INITIATION AT THE CORNER OF A KEYWAY THAT LINKED THE SPLINE TO THE SHAFT OF THE MOTOR ASSEMBLY. THE OVERLOAD FRACTURE APPEARED TO BE CAUSED BY AN UPSET LOADING CONDITION WHERE EXCESSIVE FORCE HAS BEEN APPLIED TO THE SPLINE WHEN THE KEY WAS PULLED UP BY ELECTRIC MAGNETIC FORCE. THE KEY WAS LOOSE DUE TO THE LACK OF LOCTITE 603 WHEN THE COUCH WAS BUILT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE UNLOADING OF A PATIENT, AFTER THE PROCEDURE HAD COMPLETED SUCCESSFULLY, WHEN THE COUCH WAS MOVING OUT OF THE GANTRY, IT MOVED DOWN BY ITSELF UN-COMMANDED. A PHILIPS SERVICE ENGINEER (PSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE PSE REPORTED THAT THE COUCH'S VERTICAL BRAKE HAD FAILED. THE PSE EVALUATED THE SYSTEM AND SHUT DOWN OPERATION OF SYSTEM AND HAS ORDERED A NEW COUCH TO RESOLVE THE ISSUE. THE PSE REPORTED THE FAILED COUCH IS BEING SENT TO THE FACTORY TO BE ANALYZED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE UNLOADING OF A PATIENT, AFTER THE PROCEDURE HAD COMPLETED SUCCESSFULLY, WHEN THE COUCH WAS MOVING OUT OF THE GANTRY, IT MOVED DOWN BY ITSELF UN-COMMANDED. A PHILIPS SERVICE ENGINEER (PSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE PSE REPORTED THAT THE COUCHVERTICAL BRAKE HAD FAILED. THE PSE EVALUATED THE SYSTEM AND SHUT DOWN OPERATION OF SYSTEM AND HAS ORDERED A NEW COUCH TO RESOLVE THE ISSUE. THE PSE REPORTED THE FAILED COUCH IS BEING SENT TO THE FACTORY TO BE ANALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589074 INGENUITY CORE128 SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728323

    Patients

    Seq Age Sex Outcome Treatment
    1