BEUDAMED
    FDA Adverse Event Summary report: N

    OASIS HIGH-FIELD BORE-LESS MR

    MDR report key: 4416409 · Received January 7, 2015

    Report

    Report Number
    4416409
    Date Received
    January 7, 2015
    Date of Event
    December 9, 2014
    Report Date
    January 7, 2015
    Manufacturer
    HITACHI MEDICAL SYSTEMS AMERICA, INC.
    Product Code
    LNI
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    A NON-MRI COMPATIBLE WHEELCHAIR WAS BROUGHT INTO THE MRI ROOM DURING PATIENT TRANSPORT. DURING PATIENT TRANSFER FROM WHEELCHAIR TO MRI TABLE, THE WHEELCHAIR BECAME AFFIXED TO THE MRI MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14558 OASIS HIGH-FIELD BORE-LESS MR SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNI HITACHI MEDICAL SYSTEMS AMERICA, INC. 810564 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR