BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA ARTIST

    MDR report key: 16354554 · Received February 10, 2023

    Report

    Report Number
    3010949642-2023-00001
    Event Type
    Injury
    Date Received
    February 10, 2023
    Report Date
    April 12, 2023
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K202238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 PROPER HEARING PROTECTION DURING THE SCAN. HUMAN 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 · 0

    (B)(6) 2022. 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

    THE CUSTOMER RECEIVED NOTIFICATION FROM A PATIENT WHICH STATED THAT AFTER HAVING AN MRI, THEY DEVELOPED TINNITUS. THE PATIENT, WHO HAD BEEN PROVIDED EAR PLUGS, COMPLAINED ABOUT THE NOISE DURING THE EXAM. AT THAT TIME, HEADPHONES WERE ADDED FOR ADDITIONAL PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078805 SIGNA ARTIST NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other