BEUDAMED
    FDA Adverse Event Death Summary report: N

    NUCLEAR MAGNETIC RESONANCE IMAGING

    MDR report key: 8117181 · Received November 29, 2018

    Report

    Report Number
    2183553-2018-00018
    Event Type
    Death
    Date Received
    November 29, 2018
    Date of Event
    October 31, 2018
    Report Date
    January 9, 2019
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K163331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. UNIQUE IDENTIFIER: UDI NOT YET ASSIGNED. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION BY GE HEALTHCARE (GEHC) HAS BEEN COMPLETED. DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER, IT IS INCONCLUSIVE AS TO THE ROOT CAUSE OF THE EVENT. IT HAS BEEN CONCLUDED, HOWEVER, THAT GEHC IS NOT AT FAULT. GEHC REVIEWED THE CONTRACTUAL AGREEMENTS AND DETERMINED THAT SAFE MAGNET HANDLING AND INSTALLATION WAS THE RESPONSIBILITY OF THE RIGGING COMPANY. MAGNET DELIVERY, WHICH INCLUDES UNLOADING, MOVEMENT TO THE MR SUITE, LEVELING AND BOLTING THE MAGNET IN PLACE, ARE THE RESPONSIBILITIES OF THE RIGGING COMPANY AND NOT GEHC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A MAGNET WAS BEING LIFTED BY A CRANE FOR DEVICE INSTALLATION, THE MAGNET BECAME DETACHED FROM THE CRANE, FELL OVER AND CRUSHED A THIRD-PARTY LOGISTICS CONTRACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955220 NUCLEAR MAGNETIC RESONANCE IMAGING SIGNA ARTIST LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death