BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINIA

    MDR report key: 3576959 · Received December 31, 2013

    Report

    Report Number
    9613299-2013-00120
    Event Type
    Other
    Date Received
    December 31, 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 REPORT WAS INCORRECTLY FILED ON (B)(6) 2013 AS MDR NUMBER 9613299-2013-00121, THE CORRECT MDR SEQUENCE NUMBER SHOULD BE 9613299-2013-00120. THIS ISSUE WAS IDENTIFIED AS PRESENTING A DIFFERENT FAILURE MODE THAN THE ONE IDENTIFIED IN MDR # 9613299-2013-00001. 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 F/U 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
    682864 INFINIA SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1