BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRI 3T S

    MDR report key: 23528797 · Received November 11, 2025

    Report

    Report Number
    3013026005-2025-00004
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 11, 2025
    Manufacturer
    IMRIS IMAGING, INC
    Product Code
    LNH
    UDI-DI
    00857534006059
    PMA / PMN Number
    K133692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE MALFUNCTION. THE PATIENT WAS BEING TRANSPORTED INTO THE MRI DIAGNOSTIC ROOM BY A HOSPITAL EMPLOYEE VIA A FERROUS WHEELCHAIR AT THE TIME OF THE EVENT. IT IS UNKNOWN IF THE HOSPITAL EMPLOYEE WAS TRAINED TO BRING PATIENTS INTO THE MRI DIAGNOSTIC ROOM (ZONE 4), AND IT IS ALSO UNKNOWN IF THE WHEELCHAIR HAD APPROPRIATE OR INAPPROPRIATE ASTM LABELING. IMRIS HAS REQUESTED MORE INFORMATION REGARDING THE EVENT AND THE PATIENT INVOLVED MULTIPLE TIMES WITH NO RESPONSE BACK FROM THE CUSTOMER. THE INFORMATION RECEIVED REGARDING THE PATIENT OUTCOME WAS PROVIDED BY THE IMRIS CUSTOMER SERVICE ENGINEER. THERE WAS NO REPORTED SERIOUS HARM OR INJURY TO THE PATIENT FROM THIS EVENT. IMRIS WILL SUBMIT A FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE PATIENT WAS TRANSPORTED INTO THE MRI DIAGNOSTIC ROOM (ZONE 4) BY A HOSPITAL EMPLOYEE VIA WHEELCHAIR. THE PATIENT WAS IN A SEATED POSITION WHEN THE SEAT AND BACK SUPPORT MATERIAL BEGAN TO FOLD/COLLAPSE DUE TO THE FERROUS PROPERTIES OF THE METAL SUPPORT FRAME AS THE WHEELCHAIR WAS PULLED (ATTRACTED) TO THE MAGNET'S BORE. THE MAGNET WAS INTENTIONALLY QUENCHED BY ONE OF THE MRI TECHNOLOGIST OUT OF CONCERN FOR PATIENT SAFETY. IT WAS REPORTED THE LEFT SIDE OF THE PATIENT'S BODY MADE CONTACT WITH THE BORE. PER INFORMATION VERBALLY PROVIDED TO THE IMRIS CUSTOMER SERVICE ENGINEER, X-RAYS OF THE PATIENT WERE OBTAINED AND REPORTED AS NEGATIVE (NO SPECIFIC ANATOMIC AREA OF INTEREST WAS PROVIDED), MINOR BRUSING OF PATIENT WAS REPORTED; HOWEVER, NO SERIOUS INJURY WAS REPORTED TO THE MRI TECHNOLOGIST OR OTHERS PRESENT WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122597 IMRI 3T S MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH IMRIS IMAGING, INC 116118-000 00857534006059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other