BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINIA HAWKEYE

    MDR report key: 3522645 · Received November 29, 2013

    Report

    Report Number
    9613299-2013-00056
    Event Type
    Other
    Date Received
    November 29, 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
    K022960
    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. BASED ON ENGINEERING ANALYSIS THESE LOOSE SCREWS ON THE LINEAR BEARINGS DO NOT COMPROMISE THE STRUCTURAL INTEGRITY OF THE COMPONENT AND THEREFORE DO NOT INTRODUCE A HAZARDOUS SITUATION. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621767 INFINIA HAWKEYE SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1