BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIKOCLIP ECG MONITORING ELECTRODES

    MDR report key: 6289215 · Received January 31, 2017

    Report

    Report Number
    6289215
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Date of Event
    December 20, 2016
    Report Date
    January 30, 2017
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ECG CLIPS UTILIZED TO OBTAIN ECG TRACINGS ARE BREAKING AT AN ALARMING PACE. THIS IS A NEWER PRODUCT TO THIS FACILITY AND WITHIN 10 DAYS OF USING OVER 30 CLIPS REQUIRED REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74549 NIKOCLIP ECG MONITORING ELECTRODES ECG CLIPS DRX MORTARA INSTRUMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1