BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE 1.5T GEM HNU

    MDR report key: 6965176 · Received October 20, 2017

    Report

    Report Number
    6965176
    Event Type
    Malfunction
    Date Received
    October 20, 2017
    Date of Event
    August 21, 2017
    Report Date
    September 19, 2017
    Manufacturer
    GE HEALTHCARE
    Product Code
    MOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MRI MACHINE MALFUNCTIONED WHEN THE COIL BROKE MAKING UN-USABLE FOR PATIENT CARE. MANUFACTURER RESPONSE FOR MRI COIL, GE 1.5T GEM HNU (PER SITE REPORTER): FIELD REPRESENTATIVE TO SITE TO REPLACE MRI COIL. FIELD REPRESENTATIVE TOOK FAULTY COIL WITH HIM AFTER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744127 GE 1.5T GEM HNU COIL, MAGNETIC RESONANCE MOS GE HEALTHCARE 1.5T GEM HNU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR