BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS IMRI 3T V

    MDR report key: 24639926 · Received March 19, 2026

    Report

    Report Number
    3010326005-2026-00003
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 19, 2026
    Manufacturer
    IMRIS IMAGING, INC
    Product Code
    LNH
    UDI-DI
    00857534006745
    PMA / PMN Number
    K212367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS REPORTED DUE TO THE LENGTH OF PROCEDURAL DELAY UNDER ANESTHESIA REPORTED BY THE END USER. THE END USER REPORTED THERE WAS NO SERIOUS INJURY OR HARM TO THE PATIENT. THE MANUFACTURER HAS INITIATED INTERNAL CORRECTIVE ACTION TO FURTHER ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    THE MAGNET MOVER EXPERIENCED A MECHANICAL MALFUNCTION CAUSING AN UNEXPECTED DOWNTIME CONDITION WITH A PATIENT UNDER ANESTHESIA FOR MORE THAN ONE HOUR, LEADING TO AN EXTENDED PROCEDURAL DELAY. PER THE SITE, THE PATIENT REMAINED STABLE, AND NO ADVERSE EVENTS OR UNANTICIPATED PATIENT OUTCOMES WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED, AND THE END USER REPORTED THERE WAS NO SERIOUS INJURY OR HARM TO THE PATIENT AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697101 IMRIS IMRI 3T V System, nuclear magnetic resonance imaging LNH IMRIS IMAGING, INC 120823-000 00857534006745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other