BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 4903601 · Received July 9, 2015

    Report

    Report Number
    1525965-2015-00193
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Report Date
    June 16, 2015
    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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2015, A CUSTOMER REPORTED THAT AFTER THE INJECTION, THE ACQUISITION FAILED AND THE MESSAGE: "RESOURCE FOR ALLOCATION FAILED" WAS DISPLAYED. AFTER THE MESSAGE WAS DISPLAYED, THE TABLE MOVED DOWN AND HIT THE GANTRY. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE EVALUATED THE SYSTEM AND DETERMINED THAT THE HORIZONTAL DISPLAYS INDICATED THE TABLE HORIZONTAL POSITION WAS BETWEEN 10000 AND 13000, WHEN IT SHOULD BE BETWEEN 0 AND 1900, WHICH ALLOWED THE FOOT EXTENSION BOARD (THAT WAS MOUNTED ON THE GANTRY END OF THE COUCH) TO CONTACT THE GANTRY. THE FSE WAS ABLE TO DUPLICATE THE ISSUE. THE FSE DETERMINED THAT THE HORIZONTAL ENCODERS HAD FAILED AND THAT THE END OF THE KIRKSCREW WHERE THE RELATIVE ENCODER IS MOUNTED WAS DAMAGED. THE FSE REPLACED THE HORIZONTAL DRIVE MOTOR, KIRKSCREW, ABSOLUTE ENCODER AND THE RELATIVE ENCODER TO RESOLVE THE ISSUE. THE "RESOURCE FOR ALLOCATION FAILED" ISSUE IS ADDRESSED IN A SUBSEQUENT COMPLAINT. THE FAILED PARTS WERE NOT AVAILABLE FOR RETURN. CT ENGINEERING DETERMINED THIS ISSUE TO HAVE AN ACCEPTABLE RISK. THE FOLLOWING RISK MITIGATIONS FOR THIS ISSUE ARE AS FOLLOWS: ¿ 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. ¿ INSTRUCTION IN INSTRUCTION FOR USE TO WATCH PATIENT DURING ALL MOVEMENT. ¿ AS PER IEC 60601-1 3RD ED., CLAUSE 7.2.2, EACH DETACHABLE COMPONENT IS LABELED WITH THE FOLLOWING INFO: MANUFACTURER, MODEL (1-5). ¿ IFU LISTS APPROVED ACCESSORIES (1-5). ¿ SPECIFY, DESIGN, INSPECT AND TEST PATIENT TABLE MOTION AND DATA ACQUISITION SUBSYSTEM DESIGNS PER ESTABLISHED DEVELOPMENT STANDARDS. (1-5) ¿ 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. (1-5) ¿ DESIGN EMPLOYS NO SHARP CORNERS OR PROJECTING PARTS. (1-5) THE FSE REPLACED THE HORIZONTAL DRIVE MOTOR, KIRKSCREW, ABSOLUTE ENCODER, AND THE RELATIVE ENCODER TO RESOLVE THE ISSUE. THE CAUSE WAS NOT AVAILABLE TO BE DETERMINED DUE TO THE LACK OF PARTS BEING AVAILABLE FOR ENGINEERING EVALUATION. BASED UPON THE INFORMATION AVAILABLE, THE PROBABLE CAUSE OF THIS EVENT WAS DUE TO THE FAILED HORIZONTAL ENCODERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE TABLE MOVES DOWN IT HITS THE GANTRY. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE EVALUATED THE SYSTEM AND DETERMINED THAT THE HORIZONTAL DISPLAYS INDICATED THE TABLE HORIZONTAL POSITION WAS BETWEEN 10000 AND 13000, WHEN IT SHOULD BE BETWEEN 0 AND 1900 WHICH ALLOWED THE FOOT EXTENSION BOARD (THAT WAS MOUNTED ON THE GANTRY END OF THE COUCH) TO CONTACT THE GANTRY. THE FSE WAS ABLE TO DUPLCATE THE ISSUE. THE FSE DETERMINED THAT THE HORIZONTAL ENCODERS HAD FAILED AND THAT THE END OF THE KIRKSCREW WHERE THE RELATIVE ENCODER IS MOUNTED WAS DAMAGED. THE FSE REPLACED THE HORIZONTAL DRIVE MOTOR, KIRKSCREW, ABSOLUTE ENCODER AND THE RELATIVE ENCODER TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE TABLE MOVES DOWN IT HITS THE GANTRY. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE EVALUATED THE SYSTEM AND DETERMINED THAT THE HORIZONTAL DISPLAYS INDICATED THE TABLE HORIZONTAL POSITION WAS BETWEEN 10000 AND 13000, WHEN IT SHOULD BE BETWEEN 0 AND 1900 WHICH ALLOWED THE FOOT EXTENSION BOARD (THAT WAS MOUNTED ON THE GANTRY END OF THE COUCH) TO CONTACT THE GANTRY. THE FSE WAS ABLE TO DUPLICATE THE ISSUE. THE FSE DETERMINED THAT THE HORIZONTAL ENCODERS HAD FAILED AND THAT THE END OF THE KIRKSCREW WHERE THE RELATIVE ENCODER IS MOUNTED WAS DAMAGED. THE FSE REPLACED THE HORIZONTAL DRIVE MOTOR, KIRKSCREW, ABSOLUTE ENCODER AND THE RELATIVE ENCODER TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444760 BRILLIANCE 64 COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1