BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-TRAK 3150 MONITORING SYSTEM

    MDR report key: 439019 · Received January 18, 2003

    Report

    Report Number
    1051786-2003-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2003
    Report Date
    January 14, 2003
    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

    DURING AN INSTALLATION OF THE PT MONITOR, THE 3150 MONITOR WAS BEING MOVED INTO THE MRI MAGNET ROOM AND PLACED INTO POSITION NEAR THE MRI SCANNER. THE MONITOR'S EXTERNAL POWER SUPPLY (AS153) WAS SITTING ATOP THE BASE OF THE MONITOR, AND WHEN IT WAS LIFTED, IT WAS ACCIDENTALLY PULLED INTO THE MRI MAGNET WHEN BROUGHT TOO CLOSE TO THE MRI SCANNER. NO PATIENT WAS IN THE MRI SCANNER AT THE TIME, AND NO INJURY OCCURRED DURING THIS EVENT. THE AS153 EXTERNAL POWER SUPPLY WAS REMOVED FROM THE MRI SCANNER WITHOUT FURTHER INCIDENT OR DAMAGE TO THE SCANNER. NO DAMAGE WAS EVIDENT IN THE POWER SUPPLY AFTER THE EVENT. BOTH THE MONITOR'S INSTRUCTIONS AND LABEL ON THE POWER SUPPLY ASSEMBLY WARN THE USER TO KEEP THIS ASSEMBLY AT LEAST 10 FEET AWAY FROM THE MRI MAGNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI-TRAK 3150 MONITORING SYSTEM MRI PATIENT MONITOR DRT INVIVO RESEARCH, INC. 3150 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SIEMENS MEDICAL SYSTEMS 1.5 TESLA MRI SYSTEM 2002.