BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 20

    MDR report key: 3770605 · Received April 8, 2014

    Report

    Report Number
    3770605
    Event Type
    Death
    Date Received
    April 8, 2014
    Date of Event
    March 5, 2014
    Report Date
    April 7, 2014
    Manufacturer
    PHYSIO CONTROL
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AT 1955 PATIENT DEVELOPED VENTRICULAR FIBRILLATION. AT 1957 ATTEMPTED DEFIBRILLATION - NO SHOCK WAS DELIVERED AND THE SCREEN SHUT OFF. AT 2002 ATTEMPTED DEFIBRILLATION - NO SHOCK DELIVERED AND THE SCREEN SHUT OFF. A SECOND DEFIBRILLATOR WAS CONNECTED TO THE SAME PADS; SHOCK WAS DELIVERED. RESUSCITATION EFFORTS CONTINUED BUT CPR WAS DISCONTINUED AT 2029. PRONOUNCED DEAD AT 2030. OUTCOME OF THE EVENT MAY NOT HAVE BEEN DIFFERENT IF THE FIRST DEFIBRILLATOR HAD NOT MALFUNCTIONED BUT THERE WAS A DELAY OF CARE AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212584 LIFEPAK 20 DEFIBRILLATOR MKJ PHYSIO CONTROL LIFEPAK 20

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| O