BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "QUIK-COMBO" - ADULT PACING/DEFIBRILLATION/ECG ELECTRODES

    MDR report key: 3889040 · Received June 17, 2014

    Report

    Report Number
    MW5036740
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 6, 2014
    Manufacturer
    PHYSIO CONTROL
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A CARDIAC ARREST AND A CODE BLUE WAS INITIATED. DURING THE APPLICATION OF THE DEFIBRILLATOR, THE NURSE TRIED TO SHOCK THE PATIENT. THE PADS DID NOT WORK (NOTHING HAPPENED) WHEN ATTACHED TO THE PATIENT. A SECOND SET OF PADS/WIRES WERE OBTAINED FROM THE CRASH CART. THE PADS WERE CHANGED OUT AND THE REPLACE PADS WERE WORKING PROPERLY. THE CARE WAS ONLY DELAYED FOR A FEW SECONDS. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354621 "QUIK-COMBO" - ADULT PACING/DEFIBRILLATION/ECG ELECTRODES ELECTRODES LDD PHYSIO CONTROL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR LIFE PAK DEFIBRILLATOR 20E, SERIAL #(B)(4)