BEUDAMED
    FDA Adverse Event Summary report: N

    ADULT RADIOTRANSLUCENT ELECTRODE

    MDR report key: 4901643 · Received June 24, 2015

    Report

    Report Number
    4901643
    Date Received
    June 24, 2015
    Date of Event
    May 19, 2015
    Report Date
    June 24, 2015
    Manufacturer
    HEART SYNC, INC.
    Product Code
    MKJ
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING STAFF TRAINING, THE DEFIBRILLATOR PAD PACKAGE WAS OPENED AND THE PACKAGE WAS REMOVED FROM THE CABLE, RIPPING THE CABLE COATING AND CAUSING THE WIRES TO BE EXPOSED. NO HARM OCCURRED TO THE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408681 ADULT RADIOTRANSLUCENT ELECTRODE AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ HEART SYNC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *