BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPR STAT-PADZ, MULTI-FUNCTION, ADULT ELECTRODES

    MDR report key: 3854259 · Received May 23, 2014

    Report

    Report Number
    3854259
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING CPR ON A PATIENT, THE PADS THAT WERE APPLIED BEGAN TO UNPEEL FROM THE PATIENTS BARE CHEST. THE PADS EVENTUALLY LOST ENOUGH CONTACT WITH THE SKIN RESULTING IN LOOSING THE ELECTROCARDIOGRAM (ECG) ON THE MONITOR DEFIBRILLATOR. THIS MADE ASSESSING THE PATIENTS ECG IMPOSSIBLE POTENTIALLY LOSING AN OPPORTUNITY TO DEFIBRILLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309128 CPR STAT-PADZ, MULTI-FUNCTION, ADULT ELECTRODES NONE MKJ 0814

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR