BEUDAMED
    FDA Adverse Event Summary report: N

    BRIGHTVIEW XCT IMAGING SYSTEM

    MDR report key: 2112478 · Received March 11, 2011

    Report

    Report Number
    2916556-2011-00010
    Date Received
    March 11, 2011
    Report Date
    February 14, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND)
    Product Code
    KPS
    PMA / PMN Number
    K080927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FSE REPORTED A BREAKAGE OF THE Y LOCK SHAFT WHILE HE WAS PERFORMING THE XCT ALIGNMENT QUALITY ASSURANCE (QA) ON THE BRIGHTVIEW XCT CAMERA. THIS BREAK CAUSED THE FLAT PANEL TO DROP TOWARDS THE COLLIMATOR ON DETECTOR ONE. SINCE THE FSE WAS ON SITE PERFORMING THE XCT ALIGNMENT QUALITY ASSURANCE (QA), AS PART OF A SOFTWARE UPGRADE OF THE SYSTEM, THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIGHTVIEW XCT IMAGING SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND) 453560462131

    Patients

    Seq Age Sex Outcome Treatment
    1