BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE 1.5T SIGNA HDX MR SYSTEM

    MDR report key: 4596610 · Received March 12, 2015

    Report

    Report Number
    2183553-2015-00005
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    February 5, 2015
    Report Date
    February 6, 2015
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT CURRENTLY NOT AVAILABLE. INITIAL REPORTER EMAIL ADDRESS CURRENTLY NOT AVAILABLE. THE SYSTEM IS DESIGNED TO COMPLY WITH IEC AND (B)(4) STANDARDS FOR ACOUSTIC LIMITS AND THE WORKING SAFELY OPERATOR MANUAL 2381696 INSTRUCTS SITES TO USE HEARING PROTECTION. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT PROVIDED BY CUSTOMER. THE LOG AND IMAGE INFORMATION REVIEWED FROM THE SITE DID NOT INDICATE THERE WAS ANY SYSTEM MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THE INCIDENT. THE SYSTEM OPERATOR IS RESPONSIBLE FOR PROVIDING THE HEARING PROTECTION. IN THIS CASE, HEARING PROTECTION WAS PROVIDED AND PLACED BY THE PATIENT. ALL DATA REVIEWED INDICATES THAT THE SYSTEM WAS OPERATING NORMALLY AND WITHIN PERFORMANCE SPECIFICATIONS. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER THAT A PATIENT REPORTED HEARING LOSS AFTER AN MRI EXAMINATION. THE PATIENT COMPLAINED OF THE LOUDNESS DURING THE SCAN, AND THE MAGNACOUSTICS HEADSET THAT WAS BEING USED FOR HEARING PROTECTION WAS REPLACED WITH 29 NNR EARPLUGS. THE PATIENT WAS SCANNED FOR TWO STUDIES AND WAS IN THE SCANNER FOR APPROXIMATELY 1 HOUR. THE PATIENT INITIALLY WENT TO URGENT CARE REGARDING THE HEARING LOSS, AND THEN WAS REFERRED TO AN ENT PHYSICIAN WHERE THE HEARING LOSS WAS CONFIRMED. IT IS NOT KNOWN IF THE PATIENT HAD EXISTING HEARING LOSS PRIOR TO THE MR EXAMINATION. NO INFORMATION REGARDING MEDICAL TREATMENT OF THE PATIENT HAS BEEN PROVIDED TO GE HEALTHCARE. THERE IS NO EVIDENCE OF SYSTEM MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170263 GE 1.5T SIGNA HDX MR SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other