BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOT APPLICABLE

    MDR report key: 10902433 · Received November 25, 2020

    Report

    Report Number
    10902433
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 11, 2020
    Report Date
    November 24, 2020
    Manufacturer
    GENERAL ELECTRIC COMPANY
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    MRI TABLE DOCK MISALIGNED. MANUFACTURER RESPONSE FOR MRI, MR450W (PER SITE REPORTER). GE REPAIRED THE TABLE DOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366748 NOT APPLICABLE SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GENERAL ELECTRIC COMPANY OPTIMA MR450W 1.5T

    Patients

    Seq Age Sex Outcome Treatment
    1