BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FONAR INDOMITABLE AKA UPRIGHT¿ MRI

    MDR report key: 7630585 · Received June 22, 2018

    Report

    Report Number
    2432211-2018-00001
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    May 14, 2018
    Report Date
    June 18, 2018
    Manufacturer
    FONAR CORPORATION
    Product Code
    LNH
    PMA / PMN Number
    K002490
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVIDENCE THAT THE SYSTEM MALFUNCTIONED. THE FIELD ENGINEER EXAMINED THE MRI SYSTEM AND FOUND NO OBVIOUS DAMAGE AND REVIEW OF SUBSEQUENT IMAGES WERE FOUND TO BE WITHIN SPECIFIED LIMITS. THE SITE HAS HAD MAGNET SAFETY TRAINING AND WARNING SIGNS ARE POSTED ON THE DOOR AND ADDITIONAL SIGNS ARE POSTED THROUGH OUT THE SITE. MAGNETS INHERENTLY ATTRACT FERROUS OBJECTS. THE MAGNET FUNCTIONED WITHIN SPECIFICATION WHEN IT ATTRACTED THE FERROUS OBJECT. THE USER DOCUMENTATION FOR THE SYSTEM INCLUDES WARNINGS FOR MAGNETIC FIELD HAZARDS AND INSTRUCTIONS CONCERNING ISSUES INHERENT IN STRONG STATIC MAGNETIC FIELDS. NOTE: THIS REPORT WAS DELAYED DUE TO TECHNICAL ISSUES IN SECURING A WEB TRADER ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ENTERED THE MRI SUITE WITH A LOADED WEAPON IN HIS PANTS POCKET. THE WEAPON WAS DRAWN TOWARDS THE MAGNET AND DISCHARGED, WOUNDING THE PATIENT IN THE LEG. THE REPORT STATED THAT THE PATIENT WAS TOLD TO REMOVE EVERYTHING FROM HIS POCKETS AND THAT HE STATED EVERYTHING WAS OUT OF HIS POCKETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472684 FONAR INDOMITABLE AKA UPRIGHT¿ MRI MAGNETIC RESONANCE IMAGING SCANNER LNH FONAR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other