BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3150 MRI MONITORING SYSTEM

    MDR report key: 436262 · Received January 2, 2003

    Report

    Report Number
    1051786-2002-00012
    Event Type
    Malfunction
    Date Received
    January 2, 2003
    Date of Event
    April 16, 2002
    Report Date
    December 31, 2002
    Manufacturer
    INVIVO RESEARCH, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN MRI SCAN, A PT RECEIVED 2 "DIME-SIZED" SKIN BURNS BENEATH 2 OF THE 5 ECG ELECTRODES APPLIED TO THE PT. THE MRI TECHNOLOGIST INDICATED THAT THE ECG CABLE USED WAS A CONMED ECG CABLE (LOT NO. 0201251), WHICH IS NOT KNOWN TO BE MRI-COMPATIBLE. THIS CABLE HAS 36 INCH LENGTH METALLIC LEAD WIRES, WHICH ARE CONTRAINDICATED FOR USE IN THE MRI. THE MRI TECHNOLOGIST INSISTED THAT THIS WAS AN INVIVO CABLE, SUPPLIED TO THEM BY A MEMBER OF THE INVIVO MARKETING DEPT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention