BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA ARTIST

    MDR report key: 19310537 · Received May 14, 2024

    Report

    Report Number
    3010949642-2024-00003
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    April 9, 2023
    Report Date
    July 2, 2024
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K202238
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    H3: GE HEALTHCARE'S (GEHC) INVESTIGATION 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 SYSTEMIC ISSUES WERE IDENTIFIED AND NO CORRECTIONS ARE REQUIRED AS THE SYSTEM WAS OPERATING WITHIN SPECIFICATION. NO FURTHER ACTIONS ARE PLANNED BY GEHC. CORRECTED DATA: D4 PRIMARY UDI NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED ON MAUDE REPORT# MW5118719 SUBMITTED BY THE PATIENT, THAT FOLLOWING AN MRI SCAN FOR A C-SPINE ISSUE, THE PATIENT STATED THAT SHE WAS DIAGNOSED WITH HEARING LOSS BY AN AUDIOLOGIST. PRIOR TO THE SCAN, THE PATIENT WAS GIVEN EAR PLUGS. DURING THE SCAN, THE PATIENT WAS ALSO PROVIDED EARMUFFS AND ADDITIONAL PADDING AROUND THE EARMUFFS. IT IS UNKNOWN IF THE PATIENT RECEIVED ANY TREATMENT FOR THE HEARING LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576214 SIGNA ARTIST NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other