BEUDAMED
    FDA Adverse Event Summary report: N

    BRIGHTVIEW XCT IMAGING SYSTEM

    MDR report key: 2914853 · Received January 10, 2013

    Report

    Report Number
    1525965-2013-00006
    Date Received
    January 10, 2013
    Report Date
    December 12, 2012
    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 FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION WHERE THE CUSTOMER DURING MORNING QC, DEPLOYED THE FLAT PANEL FROM THE SYSTEM AND EXPERIENCED RESISTANCE WHEN ATTEMPTING TO ENGAGE THE LOCKING HANDLE. THE CUSTOMER REPORTED THE LOCKING HANDLE APPEARED TO BE IN PLACE. THE CUSTOMER THEN ROTATED THE GANTRY TO START ANGLE AND THE FLAT PANEL BECAME DISLODGED AND FELL INTO DETECTOR. THE CUSTOMER STATED THE SYSTEM DID NOT INDICATE THAT THE FLAT PANEL WAS NOT IN THE LOCKED POSITION. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO REPORT OF HARM TO THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14987 BRIGHTVIEW XCT IMAGING SYSTEM KPS PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 882482

    Patients

    Seq Age Sex Outcome Treatment
    1