BEUDAMED
    FDA Adverse Event Summary report: N

    BRIGHTVIEW XCT IMAGING SYSTEM

    MDR report key: 3161751 · Received June 6, 2013

    Report

    Report Number
    1525965-2013-00166
    Date Received
    June 6, 2013
    Report Date
    May 9, 2013
    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

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION THAT WHILE AN AUDIT WAS BEING CONDUCTED ON A SYSTEM IT WAS FOUND THE GROUND CONNECTION IN THE X-RAY GENERATOR WAS WITHOUT A GROUND CONNECTION AND NOT PROPERLY CONNECTED INSIDE THE X-RAY GENERATOR. THIS MAY LEAD TO AN ELECTRICAL FAULT ON THE X-RAY GENERATOR. THERE WAS NO HARM REPORTED TO A PATIENT, OPERATOR OR BYSTANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251131 BRIGHTVIEW XCT IMAGING SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 882482

    Patients

    Seq Age Sex Outcome Treatment
    1