BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICT

    MDR report key: 5108369 · Received September 28, 2015

    Report

    Report Number
    1525965-2015-00258
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Report Date
    September 1, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015, THE CUSTOMER REPORTED THAT WHILE LOADING THE PATIENT IN THE GANTRY BORE, THE MULTI-FUNCTION FOOT SWITCH WAS NOT WORKING. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE WAS NO RESCAN REQUIRED AS A RESULT OF THIS EVENT. THE FSE EVALUATED THE SYSTEM LOG FILES AND FOUND THAT THERE WERE STUCK BUTTON ERRORS INDICATING A STUCK "LOAD" BUTTON IN THE MULTI-FUNCTION FOOTSWITCH. THE FSE STATED THE ISSUE WAS CAUSED BY A MISALIGNED SWITCH IN THE MULTI-FUNCTION FOOTSWITCH ASSEMBLY THAT WAS RESOLVED BY A REALIGNMENT OF THE LOAD BUTTON IN THE MULTI-FUNCTION FOOTSWITCH. THERE WERE NO PARTS REPLACED AS A RESULT OF THIS EVENT. THE FSE ALSO CONFIRMED THAT THERE WAS NO UNCOMMANDED MOTION OF THE PATIENT SUPPORT. THE PHILIPS FSE WAS CONTACTED TO OBTAIN THE SYSTEM LOG FILES FOR FURTHER EVALUATION OF THIS REPORTED EVENT. IT WAS CONFIRMED THAT THE LOG FILES WERE NO LONGER AVAILABLE TO BE PROVIDED. BASED ON THE INFORMATION PROVIDED AND FSE INVESTIGATION, THE PROBABLE CAUSE OF THIS EVENT WAS CAUSED BY A STUCK BUTTON IN THE MULTI-FUNCTION FOOTSWITCH. CT ENGINEERING REVIEWED THIS REPORTED EVENT AND DETERMINED IT TO BE OF ACCEPTABLE RISK. THE FOLLOWING MITIGATIONS FOR THIS ISSUE INCLUDE: STOPPING HORIZONTAL MOTION IN THE PRESENCE OF RESISTANCE FORCE (NOT APPLICABLE FOR VERTICAL); TABLE COLLISION ENVELOPE; 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. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE LOADING THE PATIENT IN THE GANTRY BORE, THE MULTIFUNCTIONAL FOOT SWITCH WAS NOT WORKING. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE REVIEWED THE LOGS AND FOUND STUCK BUTTON ERRORS INDICATING A STUCK "LOAD" BUTTON. THE FSE ALSO CONFIRMED THAT THERE WAS NO UNCOMMANDED MOTION OF THE PATIENT SUPPORT. THE FSE ADJUSTED THE MULTIFUNCTIONAL FOOT SWITCH TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640087 ICT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1