BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON XL 1.5T MRI SYSTEM

    MDR report key: 17396183 · Received July 26, 2023

    Report

    Report Number
    3018423337-2023-00006
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    June 27, 2023
    Report Date
    September 1, 2023
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    K172110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON AUGUST 29, 2023, FUJIFILM HEALTHCARE CORPORATION CONCLUDED THE ROOT CAUSE INVESTIGATION. THE ROOT CASUSE OF THE REPORTED ISSUE WAS NOT DETERMINED. RECIEVER COIL PERFORMANCE TESTS WERE WITHIN SPECIFICATION AND THE HEAT GENERATION TEST SHOWED NO PROBLEMS. THE PATIENT SETTTINGS ALSO SHOWED NO PROBLEMS. THE SITE IS BEING MONITORED.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED PENDING INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    ON (B)(6), 2023, FUJIFILM HEALTHCARE CORPORATION BECAME AWARE OF AN EVENT INVOLVING ECHELON XL 1.5T MRI SYSTEM. IT WAS REPORTED THAT THE PATIENT FELT A WARMING SENSATION ON THEIR NECK DURING A CTL STUDY. FOLLOWING THE SCANS, THE PATIENT WAS SWEATING PROFUSELY AND HAD VISIBLE REDNESS. HOWEVER, NO MEDICAL TREATMENT OR SURGICAL INTERVENTION WAS REQUIRED AND THE STUDY WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO DEATH ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604919 ECHELON XL 1.5T MRI SYSTEM SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other