BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 3902587 · Received May 9, 2014

    Report

    Report Number
    1525965-2014-00103
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 10, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    CORRECTION & REMOVAL 152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE CUSTOMER AT (B)(6) REPORTED THAT THE SERVICE LATCH ON THEIR PT IMAGING TABLE OF THEIR BRILLIANCE 64 CT SYSTEM IS LOOSE FOLLOWING A PREVENTIVE MAINTENANCE (PM) VISIT THE PREVIOUS DAY. THE TECHNOLOGIST NOTICED THAT THE SERVICE LATCH FOR THE TABLE SUPPORT WAS MOVING FREE FLOAT. WHEN UNLOADING A PT FOLLOWING A COMPLETED SCAN. THE TECHNOLOGIST TRIED TO SECURE THE SERVICE LATCH, BUT DID NOT HAVE ANY TOOLS ON SITE WITH WHICH TO TIGHTEN THE NUT. THE CUSTOMER CONTACTED PHILIPS CUSTOMER SUPPORT THE SAME DAY, AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. THE FSE EVALUATED THE SYSTEM AND FOUND THAT THE SERVICE LATCH HAD BECOME LOOSE, SO TIGHTENED THE SERVICE TEE BOLT AND TESTED THE SYSTEM. THE FSE CONFIRMED THAT WITH THE SERVICE LATCH LOOSE, THE SUPPORT WOULD BE LESS FIRM AND COULD IMPACT THE REMOVAL OF THE PT FROM THE TABLE, PARTICULARLY DEPENDING ON THE WEIGHT OF THE PT. THE FSE CONFIRMED THE SYSTEM IS OPERATIONAL. THERE WAS NO REPORT OF HARM TO ANY PT, OPERATOR, OR BYSTANDER DUE TO THIS ISSUE. THERE WAS NO REPORT OF ANY IMPACT TO THE PT IMAGES DUE TO THIS ISSUE. NO DEFECTIVE PARTS WERE IDENTIFIED AND NO REPORTS WERE REPLACED. THE FSE PERFORMED AN ANALYSIS OF THE SYSTEM BUG REPORT. PREVENTIVE MAINTENANCE WAS PERFORMED ON THE SYSTEM ON (B)(4) 2014 BY THE FSE, WHICH INCLUDE RELEASING THE SERVICE LATCH TO RELEASE THE COUCH SUB FRAME IN ORDER TO ACCESS THE GANTRY. THIS ISSUE WAS SUBMITTED FOR ENGINEERING EVAL. ACCORDING TO CT ENGINEERING, WHEN A FAILURE OF THE LATCH OCCURS, THE COUCH UPPER SUBFRAME IS ALLOWED TO MOVE, TAKING WITH IT THE CARBON TOP AND POTENTIALLY ANY PT ON THE CARBON TOP AT THE TIME OF FAILURE. THERE IS NO MOTOR OR DRIVE FOR THIS, AS THE MOVEMENT OF THE SUBFRAME IS DESIGNED TO BE MANUAL BY SERVICE. THIS LATCH IS NOT INTENDED TO BE DISCONNECTED DURING CLINICAL USE. THE COUCH MOVEMENT IS ACHIEVED BY MOTORS IN THE SUBFRAME, WHICH IS LATCHED IN PLACE RELATIVE TO THE BASE, AND WHICH DRIVES THE PT SUPPORT (TABLE) DURING CLINICAL USE FOR SCANNING AND PT LOADING/UNLOADING. IF THE SUBFRAME IS NOT LATCHED TO THE BASE, THE COUCH BECOMES FREE FLOATING AT THE SUBFRAME INTERFACE, RATHER THAN THE CARBON TOP. THIS FREE-FLOATING MOTION IS SIMILAR TO THE MOTION THAT THE TRAINED USER WOULD NOTICE WHEN THE TAPE SWITCH IS USED IN EMERGENCY EXTRACTIONS. THE USERS PERFORM REGULAR QUALITY ASSURANCE (QA) TESTING, INCLUDING IMAGE QUALITY (IQ) TESTS, AS PART OF SCANNER MAINTENANCE. DURING THE QA TESTING, THE USER CONTACTS THE COUCH DURING MANUAL LOADING/UNLOADING OF THE SYSTEM PHANTOM DURING WHICH THE TRAINED USER WOULD NOTICE THE FREE-FLOATING (I.E., DISENGAGED) STATE OF THE COUCH. IF THE SERVICE LATCH IS NOT ENGAGED, AND THE USER DOES NOT DETECTED THE FREE FLOATING OF THE COUCH, THERE COULD BE COUCH POSITION ERRORS INTRODUCED DURING CLINICAL SCANS OR QA CHECKS THAT MAY NOT BE REPORTED BY THE SYSTEM AS AN ERROR TO THE OPERATOR. HOWEVER, SUCH COUCH POSITION ERRORS CAN INTRODUCE IQ TEST FAILURES DURING QA CHECKS AND INCORRECT POSITIONING DURING CLINICAL SCANS, WHICH MAY BE DETECTABLE BY THE OPERATOR. THEREFORE, IT IS EXPECTED THAT A TRAINED OPERATOR WOULD NOT PROCEED TO A CLINICAL SCAN IF QA CHECK FAILED. ADDITIONALLY, IT IS ALSO EXPECTED THAT ANY INCORRECT POSITIONING, WHICH COULD OCCUR DURING CLINICAL SCANS, WOULD NOT CAUSE INJURY TO THE PT. THE INADVERTENT MOTION OF THE SUBFRAME MAY CAUSE A POTENTIAL OPERATOR/TECH ENTRAPMENT AND PINCH NEAR THE COUCH TO GANTRY INTERFACE ON THE GANTRY BORE SIDE OF THE COUCH. THE LOCATION OF THE HAZARD IS NOT IN AN AREA WHERE THE USER WOULD NORMALLY BE FOR PT LOADING/UNLOADING OR FOR OPERATING THE SYSTEM CONTROLS FROM THE GANTRY PANEL. FURTHERMORE, THE PT IS NOT EXPECTED TO HAVE THEIR ARMS IN THE VICINITY OF THE SAME PINCH POINT AREA DURING A CLINICAL SCAN. THEREFORE, IT IS HIGHLY UNLIKELY THAT EITHER THE OPERATOR OR THE PT WILL SUFFER INJURY FROM ENTRAPMENT OR THE PINCH POINT GAP THAT RESULTS FROM THE DISPLACEMENT BETWEEN THE TABLE TOP AND THE SUBFRAME WHEN THE SERVICE LATCH IS NOT ENGAGED. THE FIELD SAFETY NOTIFICATION (FSN (B)(4)) THAT WAS SENT TO THE FILED ON APRIL 01, 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 MOVE ROBUST INSTRUCTIONS ON HOW TO SERVICE THE PT SUPPORT. THE SERVICE MANUAL CHANGES ARE INTERNAL PHILIPS DOCUMENTS. CORRECTION & REMOVAL 1525965-04/08/14-005-C WAS SUBMITTED ON APRIL 08, 2014. THIS CUSTOMER WAS CONFIRMED TO BE ON THE UNITS AFFECTED LIST 72800614 AND RECEIVED THE FSN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SERVICE LATCH ON THE PT SUPPORT TABLE TOP WAS NOT COMPLETELY SECURED TO THE SUBFRAME. THE PHILIPS CUSTOMER SUPPORT SPECIALIST CONFIRMED THAT THERE WAS NO REPORT OF HARM TO THE PT, OPERATOR, OR BYSTANDER DUE TO THIS MALFUNCTION. PHILIPS SERVICE WAS CALLED TO REPOSITION/TIGHTEN THE SERVICE LATCH TO RESOLVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282350 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1