BEUDAMED
    FDA Adverse Event Death Summary report: N

    1.5T HDX ECHOSPEED 8 CHANNEL

    MDR report key: 6038212 · Received October 18, 2016

    Report

    Report Number
    2183553-2016-00024
    Event Type
    Death
    Date Received
    October 18, 2016
    Date of Event
    August 12, 2016
    Report Date
    November 4, 2016
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K121676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION BY GE HEALTHCARE HAS BEEN COMPLETED AND CONCLUDED THAT THE ROOT CAUSE OF THE EVENT WAS INADEQUATE PATIENT SCREENING. THE 1.5 T MR SCANNER OPERATOR MANUAL STATES THAT THE USE OF YOUR MR SYSTEM IS CONTRAINDICATED (I.E., NOT ADVISED) FOR PATIENT AND MR WORKERS WITH INTRACRANIAL ANEURYSM CLIPS. THE SYSTEMS LOG AND PREVENTATIVE MAINTENANCE RECORDS WERE REVIEWED AND NO CONFIGURATION CONFLICTS WERE IDENTIFIED. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688012 1.5T HDX ECHOSPEED 8 CHANNEL NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death