BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 9343997 · Received November 19, 2019

    Report

    Report Number
    3003521780-2019-00020
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    June 20, 2019
    Report Date
    October 22, 2019
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    MKJ
    UDI-DI
    10815098020222
    PMA / PMN Number
    P160032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A POST EVENT REVIEW OF THE ELECTRONIC EVENT FILES FROM AN AED THAT WAS DEPLOYED FOR AN EVENT WHERE THE CUSTOMER REPORTED THE AED DID NOT ADVISE OR DELIVER A SHOCK, IT WAS NOTED THAT TWO DIFFERENT SETS OF PADS WERE CONNECTED TO THE AED, BUT NEITHER PADS WAS ABLE TO RECEIVE A VALID PATIENT IMPEDANCE. DURING THE EVENT, THE ELECTRONIC DATA SHOWS THE INITIAL SET OF PADS (LOT NUMBER D031518-05) WERE UNPLUGGED FROM THE AED AND THEN PLUGGED BACK IN, THEN UNPLUGGED A SECOND TIME AND A SECOND SET OF PADS (LOT NUMBER D021218-02) WERE PLUGGED IN, AND THEN UNPLUGGED. IN ALL INSTANCES, THE PATIENT IMPEDANCE WAS RARELY READABLE. THE PADS PRESENTED THE MAXIMUM MEASUREMENT OF IMPEDANCE EXCEPT FOR IN A FEW CASES WHERE THE IMPEDANCE STILL EXCEEDED THE LIMIT CONSIDERED FOR A READABLE RHYTHM. DURING THIS RESCUE, THE AED WAS NEVER ABLE TO PERFORM AN ANALYSIS OF THE PATIENT'S RHYTHM. LIKELY CAUSES OF A HIGH PATIENT PAD IMPEDANCE ARE EXCESSIVE CHEST HAIR, MOISTURE/PERSPIRATION ON THE PATIENT'S CHEST, OR PADS THAT HAVE LOST ADHESIVE AFTER BEING REMOVED AND REAPPLIED. HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138078 LIFELINE AUTOMATED EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, L.L.C. DDU-2300 10815098020222

    Patients

    Seq Age Sex Outcome Treatment
    1 Death