BEUDAMED
    FDA Adverse Event Other Summary report: N

    MRI2 MONITOR

    MDR report key: 1200323 · Received October 9, 2008

    Report

    Report Number
    9610105-2008-00024
    Event Type
    Other
    Date Received
    October 9, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    GE HEALTHCARE FINLAND OY
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MRI2 MONITOR WAS DRAWN INTO AN MRI SYSTEM. THE MRI SYSTEM WAS NOT BEING USED ON PATIENTS AT THE TIME. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRI2 MONITOR MODULAR MONITORS DRT GE HEALTHCARE FINLAND OY

    Patients

    Seq Age Sex Outcome Treatment
    1