BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 4939432 · Received July 24, 2015

    Report

    Report Number
    1525965-2015-00208
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Report Date
    June 26, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 26-JUN-2015 THE CUSTOMER AT (B)(6) REPORTED THAT THE BED WENT DOWN VIOLENTLY AND ESTOP OPENED, WHICH STOPPED ALL SYSTEM MOTIONS. A PHILIPS QUALITY ANALYST CONFIRMED THERE WAS NO HARM TO A PATIENT, OPERATOR, OR BYSTANDER AS A RESULT OF THIS EVENT. THERE WAS NO REPORT OF ANY CT RESCAN. IT WAS CLARIFIED BY THE PHILIPS QUALITY ANALYST THAT THE CUSTOMER CALLED IN FOR SUPPORT DUE TO AN ERROR MESSAGE THAT WAS PRESENTED FROM THE SYSTEM "RESOURCE ALLOCATION FAILED". IT WAS CONFIRMED THAT WHEN THIS ERROR MESSAGE APPEARED, A SYSTEM E-STOP WAS OPENED AND ALL MOTIONS WERE HALTED. THE E-STOP WAS AUTOMATICALLY OPENED BY THE SYSTEM AND NO USER INTERACTION WAS NEEDED TO OPEN E-STOP. A PHILIPS FSE WAS CONTACTED ON 28-JUL-2015 FOR ADDITIONAL INFORMATION REGARDING THIS EVENT. IT WAS CLARIFIED BY THE PHILIPS FSE THAT THE TABLE DID NOT HAVE UNCOMMANDED, VIOLENT, DOWNWARD MOTION. IT WAS CONFIRMED THAT WHEN THIS EVENT OCCURRED, THERE WAS NO IN/OUT HORIZONTAL MOTION POSSIBLE ON THE TABLE AND THE SYSTEM WAS IN AN "OPEN" ESTOP CONDITION. IT WAS ALSO CONFIRMED THAT THE SYSTEM WAS NOT ABLE TO INITIALIZE DUE TO THIS EVENT. THEREFORE, NO X-RAYS WERE ABLE TO BE PRODUCED BY THE SYSTEM AND NO PATIENT SCANNING WAS POSSIBLE. THE PHILIPS FSE INVESTIGATED THE ISSUE AND DETERMINED THAT THE ISSUE WAS CAUSED BY A DEFECTIVE HORIZONTAL MOTOR RELAY IN THE TABLE. THE PHILIPS FSE REPLACED THE DEFECTIVE MOTOR RELAY AND CALIBRATED THE TABLE TO RESOLVE THE ISSUE. THE SYSTEM WAS OPERATING AS INTENDED AFTER THIS SERVICE EVENT. THERE WERE NO PARTS OR BUG REPORT AVAILABLE FOR ENGINEERING EVALUATION. BASED ON THE DETAILS PROVIDED AND WORK PERFORMED BY THE PHILIPS FSE, THE PROBABLE CAUSE OF THIS EVENT WAS DUE TO A DEFECTIVE HORIZONTAL MOTOR RELAY IN THE COUCH. THE OVERALL RISK IS BASED ON ENGINEER'S INVESTIGATION AND ACCORDING TO THE RISK ASSESSMENT THIS REPORTED EVENT WAS DETERMINED TO BE OF ACCEPTABLE RISK. IT HAS BEEN CONCLUDED THAT IF THIS EVENT WERE TO RECUR IT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THE FOLLOWING MITIGATIONS APPLY FOR THIS ISSUE: AN EXTRA PLD DOES REDUNDANT MOTION DETECTION AND COMPARISON WITH MICROPROCESSOR BASED MEASUREMENTS. LIMIT COUCH AND TILT MOTION. CIRS MONITORS IN REAL TIME THE HORIZONTAL TABLE POSITION. THE FOLLOWING FAULT SITUATIONS SHALL BE AVOIDED BY CIRS: NO MOTION WHILE HELIX OR SURVIEW SCANNING; ANY MOTION ABOVE THRESHOLD WHILE MULTI-ROT OR CONTINUOUS SCANNING; WRONG TABLE POSITION OF ANY SCAN; WRONG TABLE POSITION OF ANY AXIAL SCAN IN A SERIES; MOTION IN A WRONG DIRECTION; IF POSITION DIFFERS MORE THAN 10 MM THEN THE PLANNED POSITION, STOP THE MOTION ACTIVITY. THE PHILIPS FSE REPLACED THE DEFECTIVE MOTOR RELAY AND CALIBRATED THE TABLE TO RESOLVE THE ISSUE. THE CAUSE WAS NOT AVAILABLE TO BE DETERMINED DO TO THE LACK OF LOGFILES AND PARTS BEING AVAILABLE FOR ENGINEERING EVALUATION. BASED UPON THE INFORMATION AVAILABLE, THE PROBABLE CAUSE OF THIS EVENT WAS DUE TO A DEFECTIVE HORIZONTAL MOTOR RELAY IN THE COUCH.

    Description of Event or Problem · 1

    BASED ON THE LIMITED INFORMATION PROVIDED, THE CUSTOMER REPORTED WHEN LOWERING THE PATIENT SUPPORT, THE PATIENT SUPPORT VIOLENTLY WENT DOWN AND E-STOP OPENED ON A BRILLIANCE 64 CT SYSTEM. ALTHOUGH THE CUSTOMER ALLEGED THE PATIENT SUPPORT WENT DOWN VIOLENTLY, A PHILIPS QUALITY ANALYST CONFIRMED THERE WAS NO HARM TO A PATIENT, OPERATOR, OR BYSTANDER, AND THAT THE E-STOP HAD OPENED STOPPING ALL SYSTEM MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484430 BRILLIANCE 64 COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1