BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 64

    MDR report key: 3142802 · Received May 30, 2013

    Report

    Report Number
    1525965-2013-00143
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Report Date
    May 2, 2013
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON 29-APR-2013, THE CUSTOMER REPORTED THAT ON (B)(6) 2013, DURING A POWER UP OF THE CT SYSTEM, WHEN THE OPERATOR CLOSED THE E-STOP USING THE KEY FROM THE GANTRY CONTROL BOX, THE PATIENT SUPPORT BEGAN TO MOVE DOWNWARDS. THE PATIENT SUPPORT STOPPED WHEN IT REACHED ITS LOWER LIMIT. THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE EVENT TOOK PLACE. THERE ARE NO REPORTS OF ANY HARM/INJURY TO A PATIENT OPERATOR OR BYSTANDER DUE TO THIS EVENT. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. ON 30-MAY-2013, THE FSE ARRIVED ON SITE AND EVALUATED THE SYSTEM. UPON EVALUATION OF THE SYSTEM, THE FSE DETERMINED THAT THE VERTICAL BRAKE DID NOT ACTUATE, THUS, NOT STOPPING THE PATIENT SUPPORT WHEN THE E-STOP WAS CLOSED. THE FSE REPLACED THE VERTICAL BRAKE KIT TO RESOLVE THE ISSUE. THE LOG FILES WERE SENT TO PHILIPS CT ENGINEERING FOR INVESTIGATION. INVESTIGATION INTO THE ISSUE BY PHILIPS ENGINEERING WAS ABLE TO CONFIRM THAT THE E-STOP OPENED FOLLOWING THE FAILED VERTICAL MOVEMENT. A PHYSICAL INVESTIGATION OF THE FAILED PART WAS NOT ABLE TO BE COMPLETED DUE TO THE FAILED PART NOT BEING RECEIVED. WITH THE LIMITED INFORMATION PROVIDED TO ENGINEERING, A CAUSE COULD NOT BE DETERMINED. SINCE THE REPLACEMENT OF THE VERTICAL BREAK ON (B)(6) 2013, THERE HAVE BEEN NO RECURRENCES OF THIS ISSUE.

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM THE CUSTOMER REPORTING. THE OPERATOR WAS POWERING UP THE CT SYSTEM IN THE MORNING AND WHEN THEY CLOSED THE ESTOP VIA THE KEY ON THE CONTROL BOX THE GANTRY POWERED UP BUT THE COUCH BEGAN TO FALL IN AN UNCONTROLLED STATE AND FELL TO THE LOWER LIMIT. THERE WAS NO HARM TO THE OPERATOR AND NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION FROM THE CUSTOMER REPORTING THE OPERATOR WAS POWERING UP THE CT SYSTEM IN THE MORNING AND WHEN THEY CLOSED THE ESTOP VIA THE KEY ON THE CONTROL BOX, THE GANTRY POWERED UP BUT THE COUCH BEGAN TO FALL IN AN UNCONTROLLED STATE AND FELL TO THE LOWER LIMIT. THERE WAS NO HARM TO THE OPERATOR AND NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238740 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1