BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART 4000

    MDR report key: 371930 · Received January 16, 2002

    Report

    Report Number
    1218950-2002-00009
    Event Type
    Death
    Date Received
    January 16, 2002
    Date of Event
    December 6, 2001
    Report Date
    December 17, 2001
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT WAS FOUND IN CARDIAC ARREST AND WAS ATTACHED TO AN M5500B IN AED MODE. THE INITIAL PRESENTATION ON THE SCREEN WAS A VENTRICULAR FIBRILLATION PATTERN, BUT THE M5500B DID NOT RECOGNIZE THE RHYTHM AND WOULD NOT ALLOW THE OFFICERS TO SHOCK THE PATIENT. A SECOND AMBULANCE WAS CALLED TO THE SCENE. THE SECOND AMBULANCE ARRIVED ON THE SCENE APPROXIMATELY 15 MINUTES AFTER THE FIRST AMBULANCE ARRIVED. THE SECOND DEFIBRILLATOR WAS ATTACHED TO THE PATIENT IN AED MODE AND SET TO RE-ANALYZE THE 'CLASSIC VENTRICULAR FIBRILLATION PATTERN' AND IT REPORTED 'CANNOT ANALYZE'. THE UNIT WAS THEN SWITCHED TO MANUAL MODE AND THE PATIENT WAS SHOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART 4000 DEFIBRILLATOR/MONITOR MKJ AGILENT TECHNOLOGIES, INC. M5500B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death