BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURKICK ELI 280

    MDR report key: 6979148 · Received October 26, 2017

    Report

    Report Number
    MW5072947
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 20, 2017
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE WAS HOOKING UP LEADS AND WIRES OF EKG TO PT. AS THE NURSE PUT A WIRE TO A LEAD, THE WIRE WENT ACROSS THE PT'S CHEST AND THE PT SAID SHE FELT SOMETHING BURNING HER. PT ASKED THE NURSE WHAT IT WAS AND NURSE TOLD HER SHE DID NOT KNOW BECAUSE THE (EKG) MACHINE WAS NOT ON. PT STATED IT WAS LIKE AN ELECTRICAL SHOCK. PT STATES SHE GOT HOME AND HAD SOME TINGLING AND FOUND A PAD LEFT ON HER CHEST, THAT IS WHEN SHE FOUND WHAT LOOKS LIKE A BURN ON HER CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760588 BURKICK ELI 280 ELECTROCARDIOGRAPH (EKG) DPS MORTARA INSTRUMENT, INC. ELI280

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR