BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA VOYAGER

    MDR report key: 11807920 · Received May 11, 2021

    Report

    Report Number
    3010949642-2021-00005
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    February 12, 2021
    Report Date
    August 18, 2021
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K161567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION BY GE HEALTHCARE HAS BEEN COMPLETED. THE ACOUSTIC PERFORMANCE TEST WAS PERFORMED ON THE SYSTEM AND CONCLUDED THAT THE TESTING MEETS THE IEC 60601-2-33 REQUIREMENTS AND THE OSHA LEVELS ARE WITHIN THE SPECIFICATION FOR THIS SYSTEM CONFIGURATION. THE INCIDENT APPEARS TO BE THE RESULT OF HUMAN MEDICAL CONDITION(S). THE PATIENT WAS PROVIDED SPECIFIED HEARING PROTECTION, HOWEVER A PATIENTS MEDICAL CONDITIONS MAY CAUSE SENSITIVITY TO ACOUSTIC LEVELS THAT OCCUR DURING NORMAL CLINICAL SCANNING. NO SYSTEM ISSUE WAS FOUND. NO CORRECTIONS ARE REQUIRED AS THE SYSTEM WAS OPERATING WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER: (B)(4). THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER THAT A PATIENT WITH A PRE-EXISTING HEARING CONDITION UNDERWENT AN MR EXAMINATION OF THE BRAIN. THE PATIENT REQUESTED TO USE HIS OWN EARPLUGS FOR THE EXAM, BUT THE TECHNOLOGIST ALSO PLACED THE MUSIC HEADPHONES ON THE PATIENT. THE PATIENT DID NOT COMPLAIN OF NOISE DURING THE STUDY. APPROXIMATELY A MONTH AND A HALF AFTER THE EXAMINATION, THE PATIENT REPORTED THAT HIS TINNITUS HAD WORSENED. SINCE THAT TIME, THE CUSTOMER REPORTED THAT THE PATIENT'S CONDITION WAS IMPROVING BUT AT THIS TIME, WE HAVE NOT RECEIVED INFORMATION THAT HIS CONDITION IMPROVED TO HIS PRE-MRI STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701088 SIGNA VOYAGER NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other