BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINIA

    MDR report key: 3522611 · Received November 29, 2013

    Report

    Report Number
    9613299-2013-00044
    Event Type
    Other
    Date Received
    November 29, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    GE MEDICAL SYSTEMS F.I. HAIFA
    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 MEASURED GAPS DO NOT COMPROMISE THE STRUCTURAL INTEGRITY OF THE COMPONENT AND THEREFORE DO 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 MEASURED A GAP BETWEEN THE LINEAR RAILS AND ROTOR. NO SCREWS WERE LOOSE ON THE ASSOCIATED LINER RAILS. NO DETECTOR FALL EVENT AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621801 INFINIA SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS F.I. HAIFA

    Patients

    Seq Age Sex Outcome Treatment
    1