BEUDAMED
    FDA Adverse Event Summary report: N

    BRIGHTVIEW XCT IMAGING SYSTEMS

    MDR report key: 1942938 · Received November 19, 2010

    Report

    Report Number
    2916556-2010-00022
    Date Received
    November 19, 2010
    Report Date
    October 21, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    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. WE WILL FILE A F/U MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A METAL COVER DETACHED FROM THEIR BRIGHTVIEW XCT SYSTEM DURING A ROTATIONAL SPECT SCAN AND HIT THE PATIENT IN THE HEAD. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1