BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA ARTIST

    MDR report key: 12822842 · Received November 16, 2021

    Report

    Report Number
    3010949642-2021-00007
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    September 30, 2021
    Report Date
    December 14, 2021
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K163331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 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 DURING THE SCAN. HUMAN CONDITION 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 · 0

    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 · 0

    IT WAS REPORTED THAT FOLLOWING AN MRI OF THE CERVICAL SPINE, A PATIENT COMPLAINED OF THE NOISE. THE PATIENT WAS SEEN BY THEIR PHYSICIAN AND DIAGNOSED WITH PERSISTENT TINNITUS. THERE HAVE BEEN NO CHANGES TO THE PATIENT'S CONDITION. THE PATIENT WAS PROVIDED EAR PLUGS FOR THE EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1717286 SIGNA ARTIST NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other