BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 16 AIR

    MDR report key: 3973028 · Received April 29, 2014

    Report

    Report Number
    1525965-2014-00081
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    March 30, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Removal / Correction Number
    1525965-04/08/14-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2014, THE CUSTOMER AT (B)(6) HOSPITAL, (B)(6) REPORTED THAT THE PATIENT IMAGING TABLE OF THEIR BRILLIANCE 64 CT SYSTEM IS COMING OUT TOO FAR AND THAT THE SERVICE LATCH IS LOOSE. THE CUSTOMER CONTACTED PHILIPS AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE THE SAME DAY. THE FSE EVALUATED THE SYSTEM AND FOUND THAT THE SERVICE LATCH HAD BECOME LOOSE, WHICH CAUSED THE LOWER BASE TABLE TO FREE FLOAT. THERE WAS NO REPORT OF HARM TO ANY PATIENT, OPERATOR, OR BYSTANDER DUE TO THIS ISSUE. THERE WAS NO REPORT OF ANY IMPACT TO THE PATIENT IMAGES DUE TO THIS ISSUE. THE FSE PUSHED THE TABLE IN PLACED AND TIGHTENED THE SERVICE LATCH WING NUT. NO DEFECTIVE PARTS WERE IDENTIFIED AND NO PARTS WERE REPLACED. THE FSE CONFIRMED THE SYSTEM IS FULLY FUNCTIONAL. THE FSE ALLEGED THAT AS THE CUSTOMER LOADS AND UNLOADS PATIENTS, THE SERVICE LATCH COULD HAVE BECOME LOOSE OVER TIME. PREVENTIVE MAINTENANCE(PM) WAS PERFORMED ON THE SYSTEM ON (B)(4) 2014 BY THE FSE, WHICH INCLUDES UNSCREWING THE WING NUT TO RELEASE THE SUBFRAME IN ORDER TO ACCESS THE GANTRY. THUS, IT IS POSSIBLE THAT THE WING NUT WAS NOT TIGHTENED SUFFICIENTLY AT THE END OF THE PM SESSION. THIS ISSUE WAS SUBMITTED FOR ENGINEERING EVALUATION. ACCORDING TO ENGINEERING EVALUATION: WHEN A FAILURE OF THE LATCH OCCURS, THE COUCH UPPER SUBFRAME IS ALLOWED TO MOVE, TAKING WITH IT THE CARBON TOP AND POTENTIALLY ANY PATIENT ON THE CARBON TOP AT THE TIME OF FAILURE. THERE IS NO MOTOR OR DRIVE FOR THIS, AS THE MOVEMENT OF THE SUB FRAME 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 PATIENT SUPPORT (TABLE) DURING CLINICAL USE FOR SCANNING AND PATIENT 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 DETECT 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 PATIENT. THE INADVERTENT MOTION OF THE SUB-FRAME MAY CAUSE A POTENTIAL OPERATOR/TECHNICIAN ENTRAPMENT AND PINCH POINT 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 PATIENT LOADING/UNLOADING OR FOR OPERATING THE SYSTEM CONTROLS FROM THE GANTRY PANEL. FURTHERMORE, THE PATIENT 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 PATIENT WILL SUFFER INJURY FROM ENTRAPMENT OR THE PINCH POINT GAP THAT RESULTS FROM THE DISPLACEMENT BETWEEN THE TABLETOP AND THE SUB-FRAME WHEN THE SERVICE LATCH IS NOT ENGAGED. FIELD SAFETY NOTIFICATION (FSN 72800614) THAT WAS SENT TO THE FIELD ON 08-APR-2014 STATING THAT "IF THE CUSTOMER EXPERIENCES A HORIZONTAL, TREE-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. THE PROBABLE CAUSE OF THE SERVICE LATCH WING NUT BEING LOOSE IS THAT IT WAS NOT SUFFICIENTLY TIGHTENED BY THE FSE FOLLOWING PLANNED MAINTENANCE. THE FSE TIGHTENED THE SERVICE LATCH TO RESOLVE THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SERVICE LATCH ON THE SUPPORT TABLE TOP WAS NOT COMPLETELY SECURED TO THE SUBFRAME. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO THE PT, OPERATOR, OR BYSTANDER DUE TO THIS MALFUNCTION. THE FSE WAS ABLE TO REPOSITION/TIGHTEN THE SERVICE LATCH TO RESOLVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255558 BRILLIANCE 16 AIR JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728246

    Patients

    Seq Age Sex Outcome Treatment
    1