BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHONE

    MDR report key: 540599 · Received March 19, 2004

    Report

    Report Number
    1226563-2004-00001
    Event Type
    Other
    Date Received
    March 19, 2004
    Date of Event
    March 17, 2004
    Report Date
    March 19, 2004
    Manufacturer
    ONI, MEDICAL SYSTEMS INC.
    Product Code
    LNH
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT WAS POSITIONED WITH THEIR LEFT LEG IN THE MAGNET. THE TECH DESCRIBED THEMSELVES AS BEING LOCATED IN THE DOORWAY OF THE EXAM ROOM HOLDING 3" -4" LONG, 1/2" DIAMETER TEST MAGNET IN THEIR RIGHT HAND. THEY STATED THAT, THE MAGNET ON THEIR RIGHT HAND WAS SUDDENLY ATTRACTED TO THE BORE OF THE ORTHONE, DRAGGING THEM ACROSS THE FLOOR A DISTANCE OF 7 FEET. THE TEST MAGNET STILL IN THEIR RIGHT HAND STRUCK THE RIGHT SIDE OF THE MAGNET FACE BRUISING THEIR KNUCKLES. THE TEST MAGNET AND THEIR HAND WERE DRAWN INTO THE BORE TRAPPING THEM AND INJURING THE LEG OF THE PT. THE PATIENT'S LEG INJURY WAS DESCRIBED AS A SMALL CUT MADE THROUGH THEIR JEANS BY THE TEST MAGNET. THE TECH WAS ABLE TO FREE THEIR HAND FROM THE TEST MAGNET BUT THE PT'S LEG WAS STILL PINCHED AND TRAPPED BY THE TEST MAGNET. THE TECH ACTIVATED THE EMERGENCY QUENCH BUTTON. THE SOUND OF THE MAGNET QUENCHING FURTHER DISTRESSED THE PT AND THEIR FAMILY MEMBER WHO WAS ALSO PRESENT. THE PT WAS ABLE THEN TO BE REMOVED FROM THE MAGNET. THE EVENT DESCRIBED ABOVE WAS WITH REGARD TO THE ORTHONE SYSTEM.

    Description of Event or Problem · 2

    A PT WAS POSITIONED WITH THEIR LEFT LEG IN THE MAGNET. THE TECH DESCRIBED THEMSELVES AS BEING LOCATED IN THE DOORWAY OF THE EXAM ROOM HOLDING 3"-4" LONG, 1/2" DIAMETER TEST MAGNET IN THEIR RIGHT HAND. SHE STATED THAT THE MAGNET IN HER HAND WAS SUDDENTLY ATTRACTED TO THE BORE OF THE ORTHONE, DRAGGING HER ACROSS THE FLOOR A DISTANCE OF 7 FEET. THE TEST MAGNET STILL IN HER RIGHT HAND STRUCK THE RIGHT SIDE OF THE MAGNET FACE BRUSING HER KNUCKLES. THE TEST MAGNET AND HER HAND WERE DRAWN INTO THE BORE TRAPPING HER HAND AND INJURING THE LEG OF THE PT. THE PT'S LEG INJURY WAS DESCRIBED AS A SMALL CUT MADE THROUGH THEIR JEANS BY THE TEST MAGNET. THE TECH WAS ABLE TO FREE THEIR HAND FROM THE TEST MAGNET BUT THE PT'S LEG WAS STILL PINCHED AND TRAPPED BY THE TEST MAGNET. THE TECH ACTIVATED THE EMERGENCY QUENCH BUTTON. THE SOUND OF THE MAGNET QUENCHING FURTHER DISTRESSED THE PT AND THEIR FAMILY MEMBER WHO WAS ALSO PRESENT. THE PT WAS ABLE THEN TO BE REMOVED FROM THE MAGNET. THE EVENT DESCRIBED ABOVE WAS WITH REG-ARD TO THE ORTHONE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHONE MRI SYSTEM LNH ONI, MEDICAL SYSTEMS INC. * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other
    2 UNKNOWN Other