BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 20913771 · Received December 12, 2024

    Report

    Report Number
    3010949642-2024-00008
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 15, 2024
    Report Date
    February 20, 2025
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K161567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 HEALTHCAREÂS (GEHC) INVESTIGATION HAS BEEN COMPLETED. AN ACOUSTIC PERFORMANCE TEST WAS PERFORMED PER NEMA STANDARDS PUBLICATION NO. (B)(4) (ACOUSTIC NOISE MEASUREMENT PROCEDURE FOR DIAGNOSTIC MAGNETIC RESONANCE IMAGING DEVICES) AND IEC/CEI 60601-2-33 CLAUSE 26. THE TESTING CONCLUDES THAT THE SYSTEM IS WITHIN THE SPECIFICATION FOR THIS SYSTEM CONFIGURATION. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, GEHC WAS ABLE TO CONFIRM THE PATIENT WAS PROVIDED PROPER HEARING PROTECTION FOR THE MR EXAM. THE INCIDENT APPEARS TO BE THE RESULT OF HUMAN MEDICAL CONDITION(S) THAT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, WHO HAD MRI HEADPHONES AND EAR PLUGS FOR HEARING PROTECTION, UNDERWENT AN MRI EXAM. THE PATIENT CONTACTED THE CUSTOMER THREE DAYS LATER TO REPORT HEARING ISSUES WHICH WERE CONFIRMED THAT DAY BY AN OTORHINOLARYNGOLOGIST AS HEARING LOSS OF 15 DB. IT IS UNKNOWN IF THE PATIENT RECEIVED ANY MEDICAL TREATMENT OR HAD ANY PRE-EXISTING HEARING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152265 NA NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED SIGNA VOYAGER

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other