BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 16

    MDR report key: 5091535 · Received September 21, 2015

    Report

    Report Number
    1525965-2015-00250
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Report Date
    August 31, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 31-AUG-2015, A PHILIPS FIELD SERVICE ENGINEER (FSE) ATTENDED THE SITE AND EVALUATED THE SYSTEM. THE FSE STATED THAT THE CUSTOMER WAS MOVING THE PATIENT SUPPORT UP TO MOVE THE PATIENT INTO THE GANTRY AND WHEN THE "UP" BUTTON WAS RELEASED, THE PATIENT SUPPORT CONTINUED TO MOVE UP. THE CUSTOMER PRESSED THE "UP" BUTTON AGAIN TO HALT THE CONTINUED MOTION AND THE "UP" BUTTON POPPED OFF OF THE SYSTEM. THE FSE EXAMINED THE GANTRY CONTROL PANEL AND DETERMINED THAT THE "UP" BUTTON HAD BECOME STUCK ENGAGED DUE TO LIQUID INGRESS OF INTRA-VENOUS (IV) CONTRAST MEDIA. THE FSE ORDERED A REPLACEMENT FRONT GANTRY CONTROL PANEL IF THIS MALFUNCTION WERE TO RECUR AND THE GANTRY PANEL BUTTON WERE TO BECOME STUCK ENGAGED DURING A PATIENT PROCEDURE, IT WOULD BE 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 GANTRY PANEL STUCK BUTTON FAILURES DO NOT MEET THE DEFINITION OF A MEDICAL DEVICE REPORT. THERE IS NO EVIDENCE THAT THE GANTRY PANEL STUCK BUTTON 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. ¿ ALL SYSTEMS ARE EQUIPPED WITH EMERGENCY STOP AS WELL AS POWER OFF BUTTONS WHICH PROVIDE AN IMMEDIATE MEANS FOR THE OPERATOR INSIDE THE SCAN ROOM OR IN THE CONTROL ROOM TO STOP ANY UNINTENDED TABLE MOTION, INCLUDING SUCH RESULTING FROM A STUCK GANTRY PANEL BUTTON. THE EMERGENCY STOP BUTTONS ARE VERY OBVIOUS AND LOCATED IMMEDIATELY ADJACENT TO THE GANTRY PANELS AND WITHIN REACH OF AN OPERATOR MOVING THE TABLE BY DEPRESSING ANY OF THE GANTRY BUTTONS IN QUESTION. ¿ THE SYSTEM PERFORMS A TEST FOR STUCK BUTTONS DURING INITIALIZATION. ¿ A COLLISION CALCULATION IS DONE IN EACH COMBINATION OF VERTICAL, HORIZONTAL, OR TILT MOTION, PREVENTING INJURY FROM COLLISION. ¿ MOTION CONTROL SOFTWARE VERIFIES THAT MOTION COMMANDS ARE EXECUTED OTHERWISE A FAULT CONDITION IS ASSUMED AND STOPS MOTION. ¿ RESISTANCE PROTECTION IS IN PLACE FOR COUCH HORIZONTAL MOTION, A FORCE LIMIT TO PALLET MOTION BEYOND WHICH MOTION WILL STOP AND SHUTDOWN. ¿ INSTRUCTIONS IN THE INSTRUCTIONS FOR USE TO OBSERVE THE PATIENT DURING ALL MOVEMENTS OF THE PATIENT SUPPORT. ¿ TABLE MOVEMENT THAT IS DRIVEN BY THE PRECISION MOTORS HAPPENS AT A CONTROLLED LOW SPEED. THIS PROVIDES AMPLE TIME FOR RECOGNITION OF UNWANTED MOVEMENT. AT THE SAME TIME IT PROVIDES AN OPPORTUNITY FOR MOST PATIENTS TO RESPOND TO UNINTENDED POSITIONS RESULTING FROM SUCH TABLE MOVEMENT. ¿ 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 SERIOUS INJURY TO A PATIENT, OPERATOR OR BYSTANDER AS A RESULT OF THIS MALFUNCTION OF THE GANTRY CONTROL PANEL.

    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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE POSITIONING A PATIENT FOR A CLINICAL CT PROCEDURE, THE "UP" BUTTON WAS PRESSED ON THE GANTRY CONTROL PANEL AND BECAME STUCK ENGAGED. THE OPERATOR ATTEMPTED TO STOP THE MOTION BY PRESSING THE "UP" BUTTON AGAIN, BUT THE BUTTON FELL OFF THE GANTRY CONTROL PANEL COMPLETELY WITHIN 1 SECOND AND MOTION OF THE PATIENT SUPPORT WAS HALTED. 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 EVALUATED THE CT SYSTEM AND IDENTIFIED THAT THE RIGHT HAND GANTRY CONTROL PANEL HAD CONTRAST ON IT, WHICH RESULTED IN THE STUCK BUTTON. THE FSE REPLACED THE RIGHT HAND GANTRY CONTROL PANEL TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623899 BRILLIANCE 16 COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728240

    Patients

    Seq Age Sex Outcome Treatment
    1