BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 16 AIR

    MDR report key: 3080514 · Received April 24, 2013

    Report

    Report Number
    1525965-2013-00091
    Date Received
    April 24, 2013
    Report Date
    March 29, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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). INITIAL MDR MAILED ON (B)(4) 2013.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER REPORTING THAT THEY WERE PERFORMING A SURVIEW SCAN ON A PT AND REPORTED THAT THE PT SUPPORT TOP LOWERED UNEXPECTEDLY UNTIL IT CONTACTED THE GANTRY FRONT COVER AND THE SYSTEM E-STOP OPENED, WHICH HALTED THE PROCEDURE AND TERMINATED THE EXPOSURE. NO ONE WAS INJURED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177594 BRILLIANCE 16 AIR JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728246

    Patients

    Seq Age Sex Outcome Treatment
    1