BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO RESEARCH

    MDR report key: 372086 · Received January 15, 2002

    Report

    Report Number
    1051786-2002-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2002
    Date of Event
    November 4, 2001
    Report Date
    January 10, 2002
    Manufacturer
    INVIVO RESEARCH INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER A PATIENT MRI SCAN THE PATIENT MONITOR AND ITS SEPARATE POWER SUPPLY WERE BEING MOVED OUTSIDE THE MRI MAGNET ROOM. THE MRI TECHNOLOGIST WAS CARRYING THE POWER SUPPLY PAST THE MRI BORE OPENING, AND MRI TECHNOLOGIST FELT THE POWER SUPPLY PULL OUT OF MRI TECHNOLOGIST'S HANDS, AND IT WAS PULLED INTO THE MRI BORE. THE TECHNOLOGIST WAS APPROXIMATELY 4.5 TO 5 FEET FROM THE OPENING OF THE MRI BORE. NO INJURY OCCURRED. THE MRI STAFF WERE ABLE TO REMOVE THE POWER SUPPLY WITHOUT ANY PROBLEM. NO DAMAGE WAS EVIDENT IN THE POWER SUPPLY. BOTH THE MONITOR'S INSTRUCTIONS AND A LABEL ON THE POWER SUPPLY ASSEMBLY WARN THE OPERATOR TO KEEP THIS ASSEMBLY ATLEAST 10 FEET AWAY FROM THE MRI MAGNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO RESEARCH MRI PATIENT MONITOR DRT INVIVO RESEARCH INC. AS153 (PART OF 3150 SYSTEM) 327370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other G.E. MEDICAL 1.0 TESLA HORIZON LX MRI SCANNER.