BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIGHTVIEW IMAGING SYSTEM

    MDR report key: 1759926 · Received June 29, 2010

    Report

    Report Number
    2916556-2010-00004
    Event Type
    Malfunction
    Date Received
    June 29, 2010
    Report Date
    December 3, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    KPS
    PMA / PMN Number
    K062298
    Removal / Correction Number
    2916556-07/02/09-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING RETROSPECTIVELY SUBMITTED UPON RECENT KNOWLEDGE OF A SIMILAR COMPLAINT FOR WHICH MDR WAS SUBMITTED PREVIOUSLY. PHILIPS HAS IMPLEMENTED A CORRECTION TO THE FIELD WHEREBY A SAFETY PLATE WAS ADDED TO THE ASSEMBLY IN ORDER TO PREVENT THE DETECTOR FROM SLIDING TO ITS HARDWARE LIMIT, IN THE EVENT THAT THE LEAD SCREW NUT ASSEMBLY SEIZES AND FAILS. THIS CORRECTION HAS BEEN REPORTED TO FDA AS A CLASS II CORRECTION, UNDER REPORTING NUMBER 2916556-07/02/09-002C. THE FIELD ACTION HAS BEEN COMPLETED AND THE FDA GRANTED THE REQUEST TO TERMINATE THE RECALL ON 4/13/2010. (B)(4).

    Description of Event or Problem · 1

    THIS MDR IS BEING RETROSPECTIVELY SUBMITTED UPON RECENT KNOWLEDGE OF A SIMILAR COMPLAINT FOR WHICH MDR WAS SUBMITTED PREVIOUSLY. PMS RECEIVED A COMPLAINT FROM A PMS FIELD ENGINEER RAISING A CONCERN THAT BRIGHTVIEW RADIUS DRIVE LEADSCREW (B)(4) AND THE FLANGED BALL NUT (B)(4) ARE SHIPPED SEPARATELY AND NOT PREASSEMBLED. IT IS REALLY HARD TO MOUNT THESE TWO PARTS IN THE FILED AT THE CUSTOMER SITE AND THERE IS A HIGH POSSIBILITY, THAT THE BALLS OF THE FLANGED BALL NUT ARE FALLING OFF OR IN BETWEEN THE THREAD. 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 IMAGING SYSTEM SPECT/CT SYSTEM KPS PHILIPS MEDICAL SYSTEMS, INC. 2170-3000A

    Patients

    Seq Age Sex Outcome Treatment
    1