BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 20176165 · Received September 9, 2024

    Report

    Report Number
    3010949642-2024-00004
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    August 5, 2024
    Report Date
    October 3, 2024
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K143251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: GE HEALTHCAREÂS (GEHC) INVESTIGATION HAS BEEN COMPLETED. THE MR SYSTEM WAS OPERATING WITHIN SPECIFICATIONS AND ALL SAFETY MITIGATING DEVICES WERE FUNCTIONAL WHEN CHECKED BY THE GEHC FIELD ENGINEER. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, GEHC WAS ABLE TO CONFIRM THE PATIENT HAD NOT BEEN PADDED TO PREVENT CONTACT TO SIDES OF THE MAGNET BORE OR TO PREVENT SKIN TO SKIN CONTACT DURING THE MRI EXAM. THE ROOT CAUSE OF THE INJURY WAS DETERMINED TO BE LACK OF ADEQUATE PATIENT PADDING FOR THE MRI PROCEDURE. THE OPERATOR DOCUMENTATION AND THE USER INTERFACE DESCRIBE THE APPROPRIATE SAFETY MEASURES FOR PADDING PATIENTS FOR MR EXAMS. THE MR OPERATOR HAS RESPONSIBILITY FOR THE USE AND PLACEMENT OF NON-CONDUCTIVE MR COMPATIBLE PADDING AND PREPARATION OF THE PATIENT, PRIOR TO STARTING THE MR EXAM PROCEDURE. NO FURTHER ACTIONS ARE PLANNED BY GEHC.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT SUSTAINED FULL THICKNESS BURNS TO THE LEFT HIP AND LEFT HAND DURING AN MRI OF THE LUMBAR SPINE. IT WAS REPORTED THAT THE PATIENT RECEIVED MEDICAL TREATMENT OF PLASTIC SURGERY AND CARDIOLOGICAL MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296637 NA NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED SIGNA EXPLORER

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Other