BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW XTC IMAGING SYSTEM

    MDR report key: 1759924 · Received June 29, 2010

    Report

    Report Number
    2916556-2010-00007
    Event Type
    Malfunction
    Date Received
    June 29, 2010
    Report Date
    December 10, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    KPS
    PMA / PMN Number
    K080927
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING RESPECTIVELY SUBMITTED UPON RECENT KNOWLEDGE OF A SIMILAR COMPLAINT FOR WHICH MDR WAS SUBMITTED PREVIOUSLY. (B)(4) MDR#2916556-2009-00004. (B)(4) WAS FOUND TO BE A DUPLICATE OF (B)(4).

    Description of Event or Problem · 1

    THIS MDR IS BEING RESPECTIVELY SUBMITTED UPON RECENT KNOWLEDGE OF A SIMILAR COMPLAINT FOR WHICH MDR WAS SUBMITTED PREVIOUSLY. PMS RECEIVED A COMPLAINT STATING RADIUS LEAD SCREW GOT BROKEN TWICE AND HAD TO REPLACED IT, IF PART WAS ABOUT TO GET OFF IT'S TRACK THEN PATIENTS COULD HAVE BEEN INJURED FOR SURE. IT WAS IDENTIFIED THAT THE COMPLAINT ISSUE WAS SIMILAR TO A PREVIOUSLY REPORTED ISSUE WHERE THE LEAD SCREW NUT ON THE CAMERA DETECTOR CAN COME LOOSE AND THE FAILURE CAN RESULT IN THE DETECTOR DRIFTING, UNDER THE INFLUENCE OF GRAVITY, TO ITS HARD LIMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIGHTVIEW XTC IMAGING SYSTEM SPECT/CT SYSTEM KPS PHILIPS MEDICAL SYSTEMS, INC. 453560749161

    Patients

    Seq Age Sex Outcome Treatment
    1