BEUDAMED
    FDA Adverse Event Other Summary report: N

    TANDEM D630

    MDR report key: 3536344 · Received December 2, 2013

    Report

    Report Number
    9613299-2013-00076
    Event Type
    Other
    Date Received
    December 2, 2013
    Date of Event
    July 16, 2013
    Report Date
    July 16, 2013
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FI
    Product Code
    KPS
    PMA / PMN Number
    K111445
    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 THE 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 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
    624322 TANDEM D630 SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FI

    Patients

    Seq Age Sex Outcome Treatment
    1