BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 40

    MDR report key: 4131202 · Received August 26, 2014

    Report

    Report Number
    1525965-2014-00152
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Report Date
    July 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    1525965-04/08/14-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE CUSTOMER REPORTED TO PHILIPS ON (B)(6) 2014 THAT THE SUB-FRAME LOCK CAME UNLATCHED ON THE PATIENT IMAGING TABLE TOP OF THEIR BRILLIANCE 40 CT SCANNER. THE CUSTOMER STATED THE IMAGING TABLE WAS IN "SERVICE MODE". THE SYSTEM WAS REPORTED TO HAVE BEEN IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF ANY HARM TO A PATIENT, OPERATOR, OR BYSTANDER. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS NOTIFIED AND SENT TO THE SITE TO RESOLVE THE ISSUE. THE FSE EVALUATED THE SYSTEM AND FOUND THAT THE SUB FRAME LOCK HAD COME UNLATCHED. THE FSE RE-LATCHED THE COUCH SUB FRAME TO RESOLVE THE ISSUE AND THE CT SYSTEM WAS RETURNED TO CLINICAL USE. THE SERVICE LOCK IS ONLY RELEASED DURING PREVENTIVE MAINTENANCE (PM) OR CORRECTIVE MAINTENANCE (SERVICE VISITS) IN ORDER TO MOVE THE COUCH TO ACCESS THE GANTRY. ON 19-JUL-2014, CORRECTIVE MAINTENANCE HAD BEEN PERFORMED ON THE SYSTEM THAT INVOLVED NEEDING ACCESS TO THE GANTRY. 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 CAUSE OF THE SERVICE LATCH BEING LOOSE IS THAT IT WAS NOT SUFFICIENTLY SECURED BY THE FSE FOLLOWING PREVIOUSLY COMPLETED MAINTENANCE. CT ENGINEERING DETERMINED THIS ISSUE TO BE AN ACCEPTABLE RISK AND IF THE MALFUNCTION WERE TO RECUR AND THE SERVICE LATCH WERE TO BECOME DISENGAGED AFTER SERVICING, PRIOR TO A PATIENT PROCEDURE OR DURING A PATIENT PROCEDURE, IT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE RISK BENEFIT ANALYSIS, TRENDING OF THE COMPLAINT RECORDS AND A CLINICAL EVALUATION BY A MEDICAL PHYSICIAN, IT HAS BEEN DETERMINED THAT SERVICE LATCH FAILURES DO NOT MEET THE DEFINITION OF A MEDICAL DEVICE REPORT. THERE IS NO EVIDENCE THAT THE SERVICE LATCH FAILURE HAS RESULTED IN A SERIOUS INJURY OR DEATH OR COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IF THE MALFUNCTION WERE TO RECUR. ¿SERVICE PERSONNEL ARE TRAINED TO ENGAGE THE SERVICE LATCH PROPERLY DURING ANY SERVICE ACTIVITIES THAT REQUIRE OPENING OF THE GANTRY FRONT COVER. ¿FLOATING TABLE CAN BE DETECTED BY TRAINED PERSONNEL DURING LOADING/UNLOADING A PATIENT FOR SCANNING OR LOADING A PHANTOM FOR QA CHECKS. ¿EXECUTION OF QA CHECKS PER USER INSTRUCTIONS ENABLES DETECTION OF TABLE POSITION ERRORS WHEN LOADING OR UNLOADING PHANTOM. ¿SERVICE PERSONNEL ARE INSTRUCTED TO PERFORM AUTO IQ TESTS (ACCEPTANCE/CONSTANCY AND/OR QUICK IQ TESTS) AFTER INSTALLATION, PREVENTIVE MAINTENANCE (PM), AND CORRECTIVE ACTIONS. ¿EXECUTION OF AUTO IQ TESTS, PER SERVICE INSTRUCTIONS, ENABLES DETECTION OF TABLE POSITION ERRORS. ¿FOR ONCOLOGY USAGE, POSITIONAL ACCURACY TESTING USING THE THERAPY TOP CALIBRATION PHANTOM ENABLES DETECTION OF TABLE POSITION ERRORS. ¿DURING A HELICAL SCAN, PER DESIGN, CIRS SHALL VERIFY THE COUCH IS MOVING IN THE DIRECTION SPECIFIED BY THE HOST AND SHALL STOP THE ACQUISITION IF THE COUCH POSITIONS ARE NOT UPDATED AS EXPECTED. ¿OPERATORS/USERS OF THE SYSTEM ARE SPECIFICALLY TRAINED TO POSITION A PATIENT IN SUCH A WAY THAT THERE IS ENOUGH PLAY IN ALL INDWELLING LINES AND CATHETERS TO ALLOW FOR THE TABLE MOTION THAT IS EXPECTED DURING THE SCAN. ¿THERE HAS BEEN NO REPORT OF INJURY TO A PATIENT, OPERATOR OR BYSTANDER AS A RESULT OF THE SERVICE LATCH BECOMING DISENGAGED. THE PRODUCT SAFETY COMMITTEE INCLUDES INFORMATION RELATED TO THE CORRECTION AND REMOVAL DOCUMENTS FOR THIS ISSUE INCLUDING FIELD SAFETY NOTIFICATION (FSN 72800614) THAT WAS SENT TO THE FIELD ON 08-APR-2014 STATING THAT: ¿ IF THE CUSTOMER EXPERIENCES A HORIZONTAL, FREE-FLOATING COUCH MOTION, THEY HAVE TO CONTACT THEIR FIELD SERVICE ENGINEER IMMEDIATELY. ¿ A COPY OF THIS FIELD SAFETY NOTICE HAS TO BE RETAINED WITH THE EQUIPMENT INSTRUCTIONS FOR USE (IFU). ADDITIONALLY, THE SERVICE MANUAL IS BEING REVISED TO PROVIDE MORE ROBUST INSTRUCTIONS ON HOW TO SERVICE THE PATIENT SUPPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A F/U MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REF: COMPLAINT PR #(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT SUPPORT WAS IN SERVICE MODE. THE PHILIPS CUSTOMER SUPPORT SPECIALIST (CSS) CONFIRMED THERE WAS NO HARM TO A PT, BYSTANDER OR OPERATOR. THE PHILIPS FIELD SVC ENGINEER (FSE) RE-ATTACHED THE SVC LATCH TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518286 BRILLIANCE 40 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728235

    Patients

    Seq Age Sex Outcome Treatment
    1