BEUDAMED
    FDA Adverse Event Summary report: N

    BRIGHTVIEW XCT IMAGING SYSTEM

    MDR report key: 3805827 · Received April 29, 2014

    Report

    Report Number
    1525965-2014-00085
    Date Received
    April 29, 2014
    Report Date
    April 2, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K080927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IN THIS CASE, AN OPERATOR WAS NOT ABLE TO PLACE THE FLAT PANEL DISPLAY (FPD) INTO THE STOW POSITION AND IT WAS STUCK IN THE DEPLOY POSITION. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED AND FOUND THAT THE FPD HAD COME FREE FROM THE ARM ASSEMBLY AND CONTACTED THE DETECTOR HEAD. THE PHILIPS FSE NOTICED THAT THE PINS WERE NOT ENGAGED BECAUSE A KEY WAS MISSING ON THE BACK HANDLE CAUSING THE PIN MECHANISM NOT TO FUNCTION PROPERLY FOR THE FPD ON THE BRIGHT-VIEW XCT CAMERA. THE PHILIPS FSE NOTICED THE SENSOR HAD CONTACT ON THE BOTTOM MECHANISM FOR THE FPD. 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
    256231 BRIGHTVIEW XCT IMAGING SYSTEM KPS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 882482

    Patients

    Seq Age Sex Outcome Treatment
    1