BEUDAMED
    FDA Adverse Event Summary report: N

    BRIGHTVIEW XCT IMAGING SYSTEM

    MDR report key: 3020560 · Received March 20, 2013

    Report

    Report Number
    1525965-2013-00059
    Date Received
    March 20, 2013
    Report Date
    February 28, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K080927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION THAT THE CUSTOMER REPORTED THAT WHEN PREPARING TO PERFORM QA, THE OPERATOR WAS NOT ABLE TO LOCK THE CT FLAT PANEL DETECTOR IN PLACE. THERE WAS NO REPORT OF HARM TO A PT, BYSTANDER OR TRAINED PROFESSIONAL AS A RESULT OF THIS REPORTED EVENT AND NO REPORT OF A RESCAN OR REINJECTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116187 BRIGHTVIEW XCT IMAGING SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 882482

    Patients

    Seq Age Sex Outcome Treatment
    1