BEUDAMED
    FDA Adverse Event Other Summary report: N

    MILLENNIUM VG

    MDR report key: 3530389 · Received December 3, 2013

    Report

    Report Number
    9613299-2013-00104
    Event Type
    Other
    Date Received
    December 3, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K953801
    Removal / Correction Number
    9613299-06/20/2013-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS IDENTIFIED AS PRESENTING A DIFFERENT FAILURE MODE THAN THE ONE IDENTIFIED IN MDR# 9613299-2013-00001. THE EXACT MANUFACTURING DATE IS UNK AT THIS TIME, THE YEAR OF MANUFACTURE IS 1998. IT CANNOT BE PROVEN THAT THE FAILURE ON THESE SYSTEMS COMPROMISES THE STRUCTURAL INTEGRITY OF THE COMPONENT, DUE TO SOME INACCESSIBLE SCREWS THAT COULD NOT BE INSPECTED. PER ENGINEERING ANALYSIS OF THE INSPECTED SCREWS THIS FAILURE DOES NOT INTRODUCE A HAZARDOUS SITUATION. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING SERVICE ACTIVITY RELATED TO A FIELD ACTION, A GE HEALTHCARE FIELD ENGINEER FOUND LOOSE SCREWS ON THE LINEAR BEARING. NO DETECTOR FALL EVENT AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626828 MILLENNIUM VG SYSTEM, TOMOGRAPHY, COMPUTED EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1