BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3150 MRI PATIENT MONITOR

    MDR report key: 479121 · Received August 21, 2003

    Report

    Report Number
    1051786-2003-00003
    Event Type
    Injury
    Date Received
    August 21, 2003
    Date of Event
    July 15, 2003
    Report Date
    August 15, 2003
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN MRI SCAN, AN ANESTHETIZED PT RECEIVED A SKIN BURN ACROSS THEIR LOWER LEG (TIBIA AREA). A PORTION OF THE ECG CABLE WAS ATOP THE PT'S LOWER LEG, AND THIS CABLE SHOWED SIGNS OF HEATING. THE INSULATION OF SOME OF THE INDIVIDUAL LEAD WIRES AT THIS PLACE IN THE CABLE HAD BEEN MELTED. THIS ECG CABLE USED WAS NOT INTENDED FOR USE WITH THIS PT MONITOR. THE ECG CABLE WAS THE GE MRI ECG GATING CABLE USED WITH THEIR MRI SCANNER. PT RECEIVED A SERIOUS BURN, AND IS HAVING A PLASTIC SURGICAL CONSULTATION BEING PERFORMED. THE PT MONITOR AND CABLE HAVE BEEN REMOVED FROM USE UNTIL THE HOSPITAL'S INVESTIGATION IS COMPLETE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention GENERAL ELECTRIC 1.5 TESLA MRI SCANNER| (UNK TO UNK).