BEUDAMED
    FDA Adverse Event Other Summary report: N

    TANDEM D670

    MDR report key: 3530010 · Received December 4, 2013

    Report

    Report Number
    9613299-2013-00073
    Event Type
    Other
    Date Received
    December 4, 2013
    Date of Event
    July 13, 2013
    Report Date
    July 13, 2013
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K093514
    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 THESE LOOSE SCREWS 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 FOUND LOOSE SCREWS ON THE LINEAR RAILS. NO ASSOCIATED GAPS WERE MEASURED BETWEEN THE RAILS AND ROTOR. NO DETECTOR FALL EVENT AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629813 TANDEM D670 SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1