BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK 15

    MDR report key: 7925587 · Received October 2, 2018

    Report

    Report Number
    7925587
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    August 13, 2018
    Report Date
    September 18, 2018
    Manufacturer
    PHYSIO-CONTROL, INC./PHYSIO-CONTROL MANUFACTURING, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFIB FAILURE ON EMS CALL WITH PATIENT IN CARDIAC ARREST. CREW RESPONDED TO A CARDIAC ARREST IN THE CITY AND ATTEMPTED TO UTILIZE THE LP 15 THE MONITOR REPORTED NO ELECTRICAL CAPTURE. ERROR CODE "ATTACH PADS/ELECTRODES". THIS WAS ATTEMPTED TWICE. CPR WAS CONTINUED AND THE PATIENT WAS TRANSPORTED TO MEDICAL CENTER IN CARDIAC ARREST. PATIENT EXPIRED IN ED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765854 LIFEPAK 15 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC./PHYSIO-CONTROL MANUFACTURING, INC. LIFEPAK 15

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA Life Threatening| R