BEUDAMED
    FDA Adverse Event Other Summary report: N

    TANDEM

    MDR report key: 3667033 · Received February 11, 2014

    Report

    Report Number
    9613445-2013-00009
    Event Type
    Other
    Date Received
    February 11, 2014
    Date of Event
    July 23, 2013
    Report Date
    July 23, 2013
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    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

    THE INITIAL MDR WAS FILED UNDER THE INCORRECT MANUFACTURING SITE. THIS REPORT IS TO CORRECT THE MANUFACTURING SITE TO GE HANGWEI MEDICAL SYSTEMS (B)(4). INSPECTION FINDING. 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 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 RAIL. NO ASSOCIATED GAP WAS MEASURED BETWEEN THE RAIL AND ROTOR. NO DETECTOR FALL EVENT AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89871 TANDEM SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE HANGWEI MEDICAL SYSTEMS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1