BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 4943251 · Received July 27, 2015

    Report

    Report Number
    1525965-2015-00209
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Report Date
    November 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2014, THE CUSTOMER, (B)(6) REPORTED THAT WHILE UTILIZING THE IN/OUT AND UP/DOWN BUTTONS ON THE GANTRY CONTROL PANELS, THE PATIENT SUPPORT DOES NOT MOVE COMPLETELY. THE OPERATOR FURTHER ADDED THAT WHILE UNLOADING THE PATIENT USING THE GANTRY CONTROL BUTTONS, THE PATIENT SUPPORT WAS NOT COMING ALL THE OUT (AWAY FROM THE GANTRY), SO THAT IT CAN BE MOVED DOWNWARDS. THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER AS A RESULT OF THIS ISSUE. THE CUSTOMER CONTACTED PHILIPS SERVICE TO INFORM THEM OF THE ISSUE AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE ARRIVED ON SITE AND CONFIRMED THE ALLEGATION OF THE CUSTOMER. THE FSE EVALUATED THE SYSTEM, CHECKED THE MECHANICAL ALIGNMENTS OF PARTS AND DETERMINED THAT THE ISSUE OCCURRED DUE TO THE ABSOLUTE ENCODER AND REAR LIMIT SWITCH NEEDING ADJUSTMENT. THE FSE ADJUSTED THEM TO RESOLVE THE ISSUE. THERE WAS NO PART REPLACEMENT. AFTER THIS SERVICE, THERE WERE NO FURTHER RECURRENCES OF THIS ISSUE AT THE SITE. NO BUG REPORTS/LOG FILES WERE PROVIDED FOR ENGINEERING EVALUATION. CT ENGINEERING INVESTIGATED THE ISSUE AND DETERMINED IT TO BE ACCEPTABLE RISK. ¿ PLANNING A SCAN BEYOND SURVIEW LIMITS TOWARDS THE IN DIRECTION IS LIMITED TO 100MM OUT OF THE SURVIEW BOUNDARIES. IN ADDITION, IN CASE THE PLAN BOX IS OUT OF SURVIEW BOUNDARIES IN THE IN DIRECTION BY ANY VALUE BETWEEN 20 TO 100MM, A WARNING TO THE USER IS DISPLAYED, IN THE CURRENT LANGUAGE, TO WATCH THE PATIENT. THIS SHALL INCLUDE PLANNING A CONTINUED SCAN ¿ LIMIT COUCH AND TILT MOTION. ¿ LIMIT SCAN PLANNING TO MAINTAIN FINGER CLEARANCE. ¿ WHEN A MOTION IS COMMANDED, THE SYSTEM (TILT AND COUCH) VERIFIES THE COMMANDED MOTION IS EXECUTED OR MOTION IS STOPPED. ¿ EMERGENCY STOP CONTROLS ON THE GANTRY PANELS AND CT OPERATION BOX REMOVES POWER FROM MOTION SYSTEM WITHIN 0.5 SECONDS AND STOPS HORIZONTAL MOTION WITHIN 10MM PER IEC 60601-1. ¿ COUCH HORIZONTAL MOTION SHALL SHUTDOWN IF A LINEAR FORCE GREATER THAN 40 POUNDS FOR STANDARD OR LOW SAG COUCHES; OR 70 POUND FOR BARIATRIC OR EXTENDED COUCHES IS ENCOUNTERED WHILE MOVING. ¿ INSTRUCTION IN INSTRUCTION FOR USE TO WATCH PATIENT DURING ALL MOVEMENT. ¿ DURING A SCAN, THE SYSTEM (CIRS) CHECKS THAT THE COUCH MOVES IN THE PLANNED DIRECTION. SCAN IS STOPPED IF THE WRONG MOTION IS DETECTED. ¿ SPECIFY, DESIGN, INSPECT AND TEST PATIENT TABLE MOTION AND DATA ACQUISITION SUBSYSTEM DESIGNS PER ESTABLISHED DEVELOPMENT STANDARDS. ¿ PATIENT TABLE BRAKING IN EMERGENCY SITUATION COMPLIES WITH IEC-601-2-32 REGULATIONS. TABLE HORIZONTAL MOTION STOPS IN LESS THAN 10MM EVEN AT SPEEDS AS HIGH AS 200MM/SEC. ¿ SPECIFY, DESIGN, INSPECT AND TEST TO MEET IEC 60601-1/ UL 60601-1 CLAUSE 23 REGULATIONS. ¿ DESIGN EMPLOYS NO SHARP CORNERS OR PROJECTING PARTS. ¿ WHEN THE COUCH HAS THE ¿BEDROCK¿ CONFIGURATION, COUCH HORIZONTAL LINEAR SHUTDOWN FORCE SHALL BE IN THE RANGE OF 70-80 POUNDS. ALSO, IF THIS MALFUNCTION WERE TO RECUR FOLLOWING A PATIENT PROCEDURE, AND A COLLISION WOULD OCCUR WITH THE FEET EXTENSION OF THE PATIENT SUPPORT TO THE GANTRY DUE TO VERTICAL ENCODER STRING BECOMING UNSEATED, THE E-STOP WOULD OPEN HALTING THE PROCEDURE. THE OPERATOR MAY REMOVE THE PATIENT FROM THE SYSTEM IN A CONTROLLED FASHION. THERE IS POTENTIAL THAT THIS ISSUE MAY RESULT IN PINCHING, ENTRAPMENT, OR REMOVING OF MEDICAL TUBING (I.E. VENTILATOR TUBING, IV TUBING, ETC.). THE TRAINED PROFESSIONAL MAY DETERMINE THAT A RESCAN IS REQUIRED. THE RISK ASSOCIATED WITH A RESCAN FROM A CT SCANNER IS ACCEPTABLE AND POSES NEGLIGIBLE HARM TO THE PATIENT. THE FSE ADJUSTED THE ABSOLUTE ENCODER AND REAR LIMIT SWITCH TO RESOLVE THE ISSUE. SINCE NO BUG REPORTS/LOG FILES WERE PROVIDED, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TABLE IS NOT MOVING ALL THE WAY IN THE OUTWARD DIRECTION TO ITS LIMIT BEFORE IT CAN BE MOVED IN THE DOWNWARD DIRECTION. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER AS A RESULT OF THIS ISSUE. THE FSE STATED THAT THE CUSTOMER HAD TO MANUALLY MOVE THE TABLE OUT. THE FSE ADJUSTED THE ABSOLUTE ENCODER AND REAR LIMIT SWITCH TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487839 BRILLIANCE 64 COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1