BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI 280

    MDR report key: 6940129 · Received October 11, 2017

    Report

    Report Number
    6940129
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    August 28, 2017
    Report Date
    September 29, 2017
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    LOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EKG GIVES ERROR MESSAGE THAT LEADS ARE NOT CONNECTED WHEN THEY ARE. EVALUATED BY BIO MET, UNABLE TO IDENTIFY CAUSE, BELIEVES LEADS EITHER NEED TO BE CLEANED OR REPLACED. BIO MED DOES NOT STOCK OR ORDER REPLACEMENT LEADS, THE DEPARTMENT WILL HAVE TO ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722655 ELI 280 ELECTROCARDIOGRAPH LOS MORTARA INSTRUMENT, INC. ELI280

    Patients

    Seq Age Sex Outcome Treatment
    1