BEUDAMED
    FDA Adverse Event Summary report: N

    BRIGHTVIEW GAMMA CAMERA SYSTEM

    MDR report key: 2112444 · Received March 23, 2011

    Report

    Report Number
    2916556-2011-00013
    Date Received
    March 23, 2011
    Report Date
    February 22, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K062298
    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 AND THEREFORE CANNOT COMPLETE SECTIONS AT THIS TIME. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE SET SCREWS ON THE COMBO HEX SLOTTED NUT ON HEAD 1 RADIUS OF BRIGHTVIEW SPECT SYSTEM CAME LOOSE. DUE TO THIS, THE COMBO NUT HAD BACKED ITSELF OFF DURING NORMAL SYSTEM USE WHICH RESULTED IN HEAD 1 LOUDLY/VIOLENTLY CHANGING POSITION DURING GANTRY ROTATION. THE SET SCREWS WERE LOOSE TO THE POINT THAT THE COMBO NUT WAS ABLE TO BE TURNED BY HAND. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIGHTVIEW GAMMA CAMERA SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 2170-3000A

    Patients

    Seq Age Sex Outcome Treatment
    1