BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MR SIGNA VOYAGER

    MDR report key: 13010984 · Received December 14, 2021

    Report

    Report Number
    MW5106041
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 19, 2018
    Report Date
    December 9, 2021
    Manufacturer
    GE HEALTHCARE MANUFACTURING LLC
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2018 IN (B)(6) AT THE (B)(6) I WAS IN (B)(6). THE PERSONS WAS IN A HOSPITAL THE (B)(6). I WAS IN THE EMERGENCY ROOM WITH A PERSONS NAMED (B)(6). THE PERSONS (B)(6) CONDUCTED A RAD CAT MRI BRAIN SCAN USING GENERAL ELECTRIC EQUIPMENT THAT CAUSED SEVERE BRAIN DAMAGE AND IMAGES OF THE SKULL. THERE WAS AN ADULT MALE BLACK HAIR COLLEGE STUDENT ON STAFF AS WELL. RADIATION OF THE BRAIN AT GENERAL ELECTRIC, IMAGES OF THE SKULL, CAT RAD MRI SCANS ON CAMPUS AT (B)(6). INSIDE OF THE (B)(6) HOSPITAL. I WAS FED NORMAL FOOD DELIVERY FAST FOOD. THEY WERE IN THE EMERGENCY ROOM HERE ONE TIME, AND WERE GIVEN IMAGING OF THE BRAIN AND SKULL. SAMPLE, HOMELESS STUDENT FROM DORMITORY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898121 MR SIGNA VOYAGER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC
    1898122 SIGNA PIONEER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Hospitalization| L| S| R HERBAL REMEDIES