BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64 AIR

    MDR report key: 3040173 · Received April 3, 2013

    Report

    Report Number
    1525965-2013-00074
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 5, 2013
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, ON 04-MAR-2013, THE CUSTOMER STATED THAT AFTER LOADING A PATIENT ON THE PATIENT SUPPORT AND PRESSING THE IN BUTTON ON THE GANTRY CONTROL PANEL, THE PATIENT SUPPORT MOVED IN THE OUT DIRECTION FOR 4 TO 5 INCHES UNTIL THE E-STOP OPENED AND HALTED ALL MOTION. THE CUSTOMER CONFIRMED THAT THERE WAS NO HARM TO A PATIENT DUE TO THIS EVENT. THE CUSTOMER CREATED A BUGREPORT AND NOTIFIED PHILIPS HELP DESK THAT THEY WOULD LIKE THE BUGREPORT REVIEWED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE TO EVALUATE THE BUGREPORT AND THE SYSTEM. THE FSE REVIEWED THE LOGFILES FROM THE SYSTEM AND DETERMINED THAT THERE WAS NO UNCOMMANDED MOTION OF THE PATIENT SUPPORT. PER THE LOGFILES, THE OPERATOR RELEASED THE BUTTON UP AND CONTINUED TO PRESS THE BUTTON IN. THE FSE WAS UNABLE TO REPRODUCE THE ISSUE AT THE CUSTOMER SITE. THE FSE CONFIRMED THAT THE LOGFILES SHOWED AN ERROR WHICH OPENED E-STOP AND HALTED ALL MOTION. THE FSE DETERMINED THAT THE ACS HAD FAILED AND REPLACED I AT THE CUSTOMER SITE TO RESOLVE THE ISSUE. THE FAILED ACS ASSEMBLY WAS AVAILABLE FOR FURTHER EVALUATION. ENGINEERING TESTED THE FAILED ACS AND WAS ABLE TO REPLICATE THE EVENT. ENGINEERING LOADED 205KG TO THE PATIENT SUPPORT TO SIMULATE THE PATIENT LOADING. WHILE PRESSING THE IN FORWARD BUTTON, THE COUCH MOVED BACK OUT AND TRIGGERED THE ERROR. FROM THIS TESTING RESULT, ENGINEERING CONCLUDED THAT THE POSSIBLE CAUSE IS THE LINEAR FORCE IS TOO LOW FOR THE DRIVE. THE LINEAR FORCE OF THIS SPECIFIC DRIVE IS 32LBS, WHICH IS LOWER THAN THE 40LBS SPECIFICATION. THIS IS DUE TO COUCH WEAR AND TEAR CAUSING THE FRICTION TO INCREASE AND THE LINEAR SHUTDOWN FORCE REDUCED TO 32LBS. WHEN SIMULATING A HEAVY PATIENT, THE FORCE TRIGGERED THE DRIVE LINEAR FORCE LIMIT (40LBS FOR STANDARD COUCH) PROTECTION AND OPENED E-STOP. ENGINEERING DETERMINED THIS ISSUE TO BE AN ACCEPTABLE RISK AND IF THE MALFUNCTION WERE TO RECUR IT WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY BECAUSE THERE ARE MULTIPLE MITIGATIONS IN PLACE: THE FOLLOWING MITIGATIONS APPLY: EMERGENCY PUSH BUTTON (MUSHROOM) IN SERVICE INSTRUCTIONS. STOP BUTTONS ON THE GANTRY PANELS AND CT OPERATION BOX. A COLLISION CALCULATION IS DONE IN EACH COMBINATION OF VERTICAL, HORIZONTAL, OR TILT MOTION. SYSTEM EMPLOYS REDUNDANT ANGLE SENSING POTENTIOMETER AND LIMIT MEASUREMENT SENSORS INTO GANTRY TILT SYSTEM DESIGN, TO DETECT IF THE COMMAND IS GIVEN AND SAFELY STOP MOTION BEYOND SPECIFIED LIMITS. THERE ARE ALSO TWO DRIVE SYSTEMS, WHICH PREVENT A SINGLE POINT FAILURE. SYSTEM EMPLOYS REDUNDANT ANGLE SENSING POTENTIOMETER AND LIMIT MEASUREMENT SENSORS INTO GANTRY TILT SYSTEM DESIGN, TO DETECT IF THE COMMAND IS GIVEN AND SAFELY STOP MOTION BEYOND SPECIFIED LIMITS. THERE ARE ALSO TWO DRIVE SYSTEMS, WHICH PREVENT A SINGLE POINT FAILURE. BUTTONS TEST DURING INITIALIZATION. COUCH CONTROL BOARD EMPLOYS REDUNDANT WATCHDOG TIMER. HORIZONTAL MOTION UTILIZED TWO INDEPENDENT ENCODERS, WHICH ARE COMPARED AGAINST EACH OTHER. CONTROLLERS SOFTWARE VERIFIES THAT COMMANDED MOTIONS ARE EXECUTED OR A FAULT CONDITION IS ASSUMED AND E-STOP CONDITION. COUCH HORIZONTAL MOTION SHALL SHUTDOWN IF A LINEAR FORCE GREATER THAN 40 POUND FOR REGULAR COUCH OR 70 POUND FOR BARIATRIC AND EXTENDED COUCHES IS ENCOUNTERED WHILE MOVING. WHEN THE COUCH HAS THE ¿BEDROCK¿ CONFIGURATION, COUCH HORIZONTAL LINEAR SHUTDOWN FORCE SHALL BE IN THE RANGE OF 70-80 POUNDS.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER REPORTING THAT WHEN PERFORMING A PT PROCEDURE AND THE OPERATOR ATTEMPTED TO POSITION THE PT SUPPORT HORIZONTALLY USING THE "IN" BUTTON ON THE GANTRY CONTROL PANEL AND REPORTED THAT THE PT SUPPORT MOVED IN THE "OUT" DIRECTION FOR 4 TO 5 INCHES UNTIL IT REACHED THE FULL OUT POSITION. THE E-STOP OPENED AND ALL MOTION WAS HALTED. THERE WAS NO REPORT OF ANY HARM TO A PT OR OPERATOR DUE TO THIS ISSUE.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER REPORTING THAT WHEN PERFORMING A PATIENT PROCEDURE AND THE OPERATOR ATTEMPTED TO POSITION THE PATIENT SUPPORT HORIZONTALLY USING THE "IN" BUTTON ON THE GANTRY CONTROL PANEL AND REPORTED THAT THE PATIENT SUPPORT MOVED IN THE"OUT" DIRECTION FOR 4 TO 5 INCHES UNTIL IT REACHED THE FULL OUT POSITION. THE E-STOP OPENED AND ALL MOTION WAS HALTED. THERE WAS NO REPORT OF ANY HARM TO A PATIENT OR OPERATOR DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136847 BRILLIANCE 64 AIR JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728246

    Patients

    Seq Age Sex Outcome Treatment
    1