BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENUITY CT

    MDR report key: 5061729 · Received September 8, 2015

    Report

    Report Number
    1525965-2015-00241
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Report Date
    August 30, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 30-AUG-2015, THE CUSTOMER REPORTED THAT DURING A PATIENT CLINICAL PROCEDURE, THE LOAD PEDAL OF THE MULTIFUNCTION FOOTSWITCH WAS STICKING. THERE WAS NO REPORT OF UNCOMMANDED MOTION OF THE PATIENT SUPPORT AND THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE OPERATOR CONTACTED THE PHILIPS HELP DESK AND A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE ARRIVED ON SITE AND EVALUATED THE SYSTEM. UPON FURTHER EVALUATION, THE FSE FOUND THAT A PLASTIC IV CAP WAS WEDGED BETWEEN THE LOAD PEDALS OF THE MULTIFUNCTION FOOTSWITCH AND THE FRAME, WHICH CAUSED THE PEDAL TO BE STUCK. THE FSE DISASSEMBLED THE FOOTSWITCH AND REMOVED THE IV CAP WHICH RESOLVED THE ISSUE. THERE WAS NO PART REPLACEMENT. THE FSE DID NOT PROVIDE THE LOG FILES FOR ENGINEERING ASSESSMENT. CT ENGINEERING DETERMINED THE EVENT TO BE AN ACCEPTABLE RISK. THE FOLLOWING MITIGATIONS FOR THIS ISSUE ARE INCLUDED FOR UNCOMMANDED MOTION OF THE PATIENT SUPPORT: THE SYSTEM IMPLEMENTS MULTIPLE MEANS TO PREVENT UNCOMMANDED MOTION AND SINGLE POINT OF FAILURE. THESE MEANS INCLUDE WATCHDOG TIMER FOR DRIVE TASKS, REDUNDANT SWITCHES IN THE CONTROL PANEL BUTTONS, COLLISION ENVELOPE AVOIDANCE SOFTWARE, PROVIDING EMERGENCY STOP BUTTONS AND EMERGENCY POWER-OFF (EPO) FOR THE USER IN CASE OF FAILURE OF OTHER DESIGN MITIGATIONS. A FAILURE DURING MOTION COULD BE CAUSED EITHER BY A SOFTWARE DEFECT IN THE EMBEDDED OPERATING SYSTEM USED OR A DEFECT IN THE CONTROL LOGIC IMPLEMENTATION, AND THE SYSTEM WAS UNABLE TO DETECT THAT. THE FAILURE COULD ONLY OCCUR DURING THE TIME WHERE THE OPERATOR INITIATED MOTION VIA THE CONTROL PANEL. IN THIS CASE, THE OPERATOR IS IN CONTACT WITH THE PATIENT AND VISUALLY WATCHING THE MOTION AND WOULD SEE THE COUCH CONTINUE TO MOVE AFTER THE BUTTON WAS RELEASED. THE TRAINED OPERATOR WOULD USE THE EMERGENCY STOP CONTROL TO STOP THE MOTION. ALSO, DESIGN MITIGATIONS FOR PREVENTION OF THE HAZARDOUS SITUATIONS INCLUDE: STOPPING HORIZONTAL MOTION IN THE PRESENCE OF RESISTANCE FORCE (NOT APPLICABLE FOR VERTICAL); TABLE COLLISION ENVELOPE; SINGLE FAULT SAFE AGAINST UNCONTROLLED MOTION: MOTION TASKS 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. DESIGN MITIGATIONS ENABLING HUMAN RESPONSE INCLUDE: 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 FSE REMOVED THE IV CAP THAT WAS BLOCKING THE PEDAL.

    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 FOOT PEDAL FOR THE UP/VERTICAL MOTION OF THE CT TABLE WAS STICKING. THERE WAS NO REPORT OF HARM TO A PATIENT, OPERATOR, OR BYSTANDER AS A RESULT OF THIS ISSUE. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE CT SYSTEM AND DISASSEMBLED THE FOOTSWITCH. THE FSE FOUND A PLASTIC SYRINGE CAP LODGED IN THE PEDAL WHICH RESULTED IN THE UP/VERTICAL PEDAL BECOMING STUCK ENGAGED. THE FSE REMOVED THE PLASTIC SYRINGE CAP FROM THE PEDAL TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FOOT PEDAL FOR THE UP/VERTICAL MOTION OF THE CT TABLE WAS STICKING. THERE WAS NO REPORT OF HARM TO A PATIENT, OPERATOR, OR BYSTANDER AS A RESULT OF THIS ISSUE. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE CT SYSTEM AND DISASSEMBLED THE FOOTSWITCH. THE FSE FOUND A PLASTIC SYRINGE CAP LODGED IN THE PEDAL WHICH RESULTED IN THE UP/VERTICAL PEDAL BECOMING STUCK ENGAGED. THE FSE REMOVED THE PLASTIC SYRINGE CAP FROM THE PEDAL TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591651 INGENUITY CT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1