BEUDAMED
    FDA Adverse Event Other Summary report: N

    MILLENIUM VG

    MDR report key: 3536347 · Received December 2, 2013

    Report

    Report Number
    9613299-2013-00071
    Event Type
    Other
    Date Received
    December 2, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FI
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS IDENTIFIED AS PRESENTING A DIFFERENT FAILURE MODE THAN THE ONE IDENTIFIED IN MDR# 9613299-2013-00001. BASED ON ENGINEERING ANALYSIS THIS BROKEN SCREW DOES NOT COMPROMISE THE STRUCTURAL INTEGRITY OF THE COMPONENT AND THEREFORE 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 THAT A SCREW ON THE LATERAL RAIL BROKE OFF AND COULDN'T BE RELEASED. NO DETECTOR FALL EVENT AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624316 MILLENIUM VG SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FI

    Patients

    Seq Age Sex Outcome Treatment
    1