BEUDAMED
    FDA Adverse Event Summary report: N

    BRIGHTVIEW XCT IMAGING SYSTEM

    MDR report key: 4213372 · Received October 24, 2014

    Report

    Report Number
    1525965-2014-00176
    Date Received
    October 24, 2014
    Report Date
    September 29, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K080927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4). INITIAL MDR MAILED ON OCTOBER 24, 2014.

    Description of Event or Problem · 1

    IN THIS CASE, AN OPERATOR WAS SETTING UP TO PERFORM THE QUALITY ASSURANCE (QA) BY EXECUTING THE "GENERAL 180" PRE-PROGRAMMED MOTION ON THEIR BRIGHTVIEW XCT. DURING THE "GENERAL 180" PPM, THE LATCH FROM THE FLAT PANEL DISPLAY (FPD) BECAME UNLATCHED AND GENERATED A SYSTEM EMERGENCY STOP ON THE SYSTEM. A SYSTEM ERROR MESSAGE APPEARED INDICATING THAT THE FPD WAS NOT PROPERLY LATCHED ON THE SYSTEM. THE OPERATOR PUSHED ON THE FPD TO REPLACE IT BACK INTO THE DEPLOY POSITION AND CONTINUED TO USE THE SYSTEM. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND FOUND A PIN ON THE LATCHING MECHANISM (OR ASSEMBLY) HAD FAILED. THE PHILIPS FSE MADE THE NECESSARY REPAIRS TO THE SYSTEM. THERE WAS NO HARM TO A PATIENT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678631 BRIGHTVIEW XCT IMAGING SYSTEM KPS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1