BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 20E

    MDR report key: 16817362 · Received April 25, 2023

    Report

    Report Number
    MW5117050
    Event Type
    Death
    Date Received
    April 25, 2023
    Date of Event
    April 9, 2023
    Report Date
    April 24, 2023
    Manufacturer
    STRYKER /PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WENT INTO CARDIOPULMONARY ARREST ON (B)(6) 2023 AT APPROX. 19:00. CPR WAS INITIATED AND THE LIFEPAK 20E DEFIBRILLATOR WAS ATTACHED. HE WAS FOUND TO BE IN PULSELESS/VF. THERE WAS AN UNFORESEEABLE MALFUNCTIONING WITH THE PATIENT'S BEDSIDE LIFEPAK 20E WHICH RESULTED IN NO DEFIBRILLATION BEING RECEIVED. DESPITE THE LIFEPAK 20E APPEARING FUNCTIONAL AND SHOWING THE DYSRHYTHMIA, IT DID NOT DISCHARGE. ULTIMATELY, PATIENT MISSED THE FIRST TWO REQUIRED DEFIBRILLATIONS IN ACCORDANCE WITH ACLS PROTOCOL DUE TO THIS MALFUNCTIONING. A NEW LIFEPAK 20E WAS OBTAINED, AND PATIENT'S FIRST DEFIBRILLATION WAS RECORDED AT 19:12. PATIENT RECEIVED MAXIMAL THERAPY INCLUDING MULTIPLE DEFIBRILLATIONS AND OTHER MEDICATIONS. WHILE ARRANGING TRANSFER TO ICU, PATIENT AGAIN WENT INTO PULSELESS VT. ACLS PROTOCOL WAS RESUMED. FAMILY WISHED TO CEASE RESUSCITATIVE EFFORTS. PATIENT DEATH PRONOUNCED AT 19:43. MANUFACTURE DATE: 05/11/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335801 LIFEPAK 20E AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ STRYKER /PHYSIO-CONTROL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other| D