BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECG SENSOR TYPE II

    MDR report key: 274504 · Received April 19, 2000

    Report

    Report Number
    MW1018717
    Event Type
    Other
    Date Received
    April 19, 2000
    Date of Event
    February 18, 2000
    Report Date
    March 29, 2000
    Manufacturer
    NIKO MEDICAL PRODUCTS
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HEMODYNAMIC CARDIAC MONITOR USED ON PT DURING MRI SCAN LASTING MORE THAN 60 MINS. CARDIAC MONITOR ELECTRODES REMOVED UPON COMPLETION OF MRI SCAN. A DIME SIZED SECOND DEGREE BURN MARK WAS NOTED AT THE SITE OF ONE OF THE ELECTRODES, UPON REMOVAL. PT DID NOT COMPLAIN OF PAIN OR DISCOMFORT DURING MRI SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECG SENSOR TYPE II PRE-GLUED SINGLE USE ELECTRODE DRX NIKO MEDICAL PRODUCTS 4110 L050999

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other