BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE BIG BORE ONCOLOGY

    MDR report key: 4990335 · Received August 11, 2015

    Report

    Report Number
    1525965-2015-00218
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Report Date
    July 13, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2015, THE CUSTOMER REPORTED THAT THE SYSTEM E-STOP SWITCH WAS NOT CLOSING AND THE CT SYSTEM DID NOT TURN ON. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE CT SYSTEM WAS NOT IN CLINICAL USE AND THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE REVIEWED THE LOGS AND FOUND STUCK BUTTON ERRORS. THE FSE DETERMINED THAT THE MULTIFUNCTION FOOT SWITCH BECAME STUCK ENGAGED AND THEREFORE, E-STOP WAS NOT CLOSING. THE FSE ALSO CONFIRMED THAT THERE WAS NO UNCOMMANDED MOTION OF THE PATIENT SUPPORT DUE TO THIS EVENT. THE PHILIPS FSE REPLACED THE MULTIFUNCTION FOOTSWITCH TO RESOLVE THE REPORTED ISSUE AND CONFIRMED PROPER SYSTEM FUNCTIONALITY. THE PHILIPS FSE WAS CONTACTED AND IT WAS DETERMINED THAT THE DEFECTIVE FOOTSWITCH WAS SCRAPPED AND NO LOG FILES WERE AVAILABLE TO BE SENT FOR EVALUATION. THEREFORE NO CAUSE WAS ABLE TO BE DETERMINED BY ENGINEERING. CT ENGINEERING DETERMINED THIS EVENT TO BE AN ACCEPTABLE RISK. THE FOLLOWING MITIGATIONS FOR THIS ISSUE INCLUDE: A. STOPPING HORIZONTAL MOTION IN THE PRESENCE OF RESISTANCE FORCE (NOT APPLICABLE FOR VERTICAL). B. TABLE COLLISION ENVELOPE. C. SINGLE FAULT SAFE AGAINST UNCONTROLLED MOTION: ¿ HORIZONTAL NODE WATCHDOG TIMER. IF MAXIMUM TIME OF CONTROL RESPONSE IS EXCEEDED, E-STOP WILL BE ACTIVATED. ¿ DOUBLE SWITCHES ON CONTROL BUTTONS PROVIDES REDUNDANCY SUCH THAT 2 SWITCHES MUST BE ACTIVATED BEFORE A MOTION IS EXECUTED. D. DESIGN MITIGATIONS ENABLING HUMAN RESPONSE: ¿ CONTINUOUS ACTIVATION FOR MANUAL MOTION. ¿ EMERGENCY STOP CONTROLS ENABLE TERMINATION OF MOTION IN HAZARDOUS CONDITION. ¿ EMERGENCY POWER OFF SWITCH SUPPLIED WITH SYSTEM OR SITE INSTALLATION ENABLES THE OPERATOR TO SHUT OFF POWER TO THE ENTIRE SYSTEM. ¿ SPEED OF MOTORIZED NON-PROGRAMMED MOTION IS LIMITED. THE PHILIPS FSE REPLACED THE MULTIFUNCTION FOOTSWITCH TO RESOLVE THE REPORTED ISSUE. THE CAUSE WAS UNABLE TO BE DETERMINED DUE TO THE DEFECTIVE FOOTSWITCH BEING SCRAPPED AND NO SYSTEM LOG FILES BEING AVAILABLE FOR ENGINEERING EVALUATION. BASED ON THE INFORMATION PROVIDED BY THE PHILIPS FSE, THE PROBABLE CAUSE WAS DUE TO A STUCK BUTTON IN THE MULTIFUNCTION FOOTSWITCH ASSEMBLY.

    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 THE E-STOP SWITCH WAS NOT CLOSING AND THE CT SYSTEM DID NOT TURN ON. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE CT SYSTEM WAS NOT IN CLINICAL USE AND THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE REVIEWED THE LOGS AND FOUND STUCK BUTTON ERRORS. THE FSE DETERMINED THAT THE MULTIFUNCTION FOOTSWITCH BECAME STUCK ENGAGED AND THEREFORE, E-STOP WAS NOT CLOSING. THE FSE ALSO CONFIRMED THAT THERE WAS NO UNCOMMANDED MOTION OF THE PATIENT SUPPORT, AND REPLACED THE MULTIFUNCTIONAL FOOTSWITCH TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE E-STOP SWITCH WAS NOT CLOSING AND THE CT SYSTEM DID NOT TURN ON. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE CT SYSTEM WAS NOT IN CLINICAL USE AND THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE REVIEWED THE LOGS AND FOUND STUCK BUTTON ERRORS. THE FSE DETERMINED THAT THE MULTIFUNCTION FOOTSWITCH BECAME STUCK ENGAGED AND THEREFORE, E-STOP WAS NOT CLOSING. THE FSE ALSO CONFIRMED THAT THERE WAS NO UNCOMMANDED MOTION OF THE PATIENT SUPPORT, AND REPLACED THE MULTIFUNCTIONAL FOOTSWITCH TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525097 BRILLIANCE BIG BORE ONCOLOGY COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1