BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 7519864 · Received May 16, 2018

    Report

    Report Number
    3008642652-2018-04480
    Event Type
    Death
    Date Received
    May 16, 2018
    Date of Event
    March 29, 2018
    Report Date
    May 16, 2018
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. DURING THE INCOMING FUNCTIONAL TESTING, A 1 HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5 HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5 HZ SIGNAL, THE DEVICE WAS CONFIRMED TO PROPERLY ENTER INTO A TREATMENT SEQUENCE WHICH INCLUDES A VERIFICATION OF THE TACTILE VIBRATION ALARM, AUDIO MESSAGING, AND SIREN ALARMS, AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER CHARGING OF THE HIGH VOLTAGE CAPACITORS AND PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER RESPONSE BUTTON FUNCTIONALITY, ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. MANUFACTURE DATES: MONITOR: 9/25/2013, ELECTRODE BELT: 08/05/2014.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2018 WHILE WEARING THE LIFEVEST. THE PATIENT WAS REPORTEDLY IN A HOSPITAL WITH STAFF PRESENT AT THE TIME OF THE EVENT. THE PATIENT'S RHYTHM WAS ASYSTOLE WITH CPR ARTIFACT. THE PATIENT'S RHYTHM THEN TRANSITIONED TO VENTRICULAR FIBRILLATION (VF) WITH VARYING AMPLITUDE AND CPR AND MOTION ARTIFACT. THE PATIENT REMAINED IN VF FOR 2.5 MINUTES BEFORE A NON-LIFEVEST DEFIBRILLATION WAS DELIVERED TO THE PATIENT. THE PATIENT'S RHYTHM AT THE TIME OF THE NON-LIFEVEST DEFIBRILLATION WAS VF, THE POST-SHOCK RHYTHM WAS A SEVEN SECOND CONVERSION WITH RECURRENT VF. THE CPR ARTIFACT, MOTION ARTIFACT, AND VARYING AMPLITUDES OF THE VF PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT. THE PATIENT REMAINED IN VF FOR 45 SECONDS BEFORE A SECOND NON-LIFEVEST DEFIBRILLATION WAS DELIVERED. THE POST-SHOCK ECG SHOWS CPR ARTIFACT. THE ELECTRODE BELT WAS DISCONNECTED AT 10:11:06 WHILE THE PATIENT WAS IN VF WITH MOTION ARTIFACT. THE PATIENT'S EQUIPMENT WAS RETURNED AND WAS FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION THE ANY DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE CPR ARTIFACT, MOTION ARTIFACT, AND VARYING AMPLITUDES OF THE VF PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361765 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death