BEUDAMED
    FDA Adverse Event Other Summary report: N

    TANDEM D670

    MDR report key: 3530026 · Received December 4, 2013

    Report

    Report Number
    9613299-2013-00117
    Event Type
    Other
    Date Received
    December 4, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 15, 2013
    Manufacturer
    GE MEDICAL SYSTEMS F.I. HAIFA
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS IDENTIFIED AS PRESENTING A DIFFERENT FAILURE MODE THAN THE ONE IDENTIFIED IN MDR NUMBER 9613299-2013-0001. BASED ON ENGINEERING ANALYSIS THIS MEASURED GAP WITH THIS LOOSE SCREW DOES NOT COMPROMISE THE STRUCTURAL INTEGRITY OF THE COMPONENT AND THEREFORE DOES NOT INTRODUCE A HAZARD. 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 IDENTIFIED ONE SCREW WITH STRIPPED THREAD ON THE LATERAL LINEAR RAIL. AN ASSOCIATED GAP WAS MEASURED BETWEEN THE LATERAL RAIL AND RADIAL CART. NO DETECTOR FALL EVENT AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629199 TANDEM D670 SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS F.I. HAIFA

    Patients

    Seq Age Sex Outcome Treatment
    1