BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 23351147 · Received October 21, 2025

    Report

    Report Number
    3008642652-2025-10200
    Event Type
    Death
    Date Received
    October 21, 2025
    Date of Event
    September 20, 2025
    Report Date
    October 21, 2025
    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 · 0

    DEVICE EVALUATION OF THE MONITOR AND ELECTRODE BELT HAS BEEN COMPLETED. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5HZ 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.

    Description of Event or Problem · 0

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2025 WHILE REPORTEDLY WEARING THE LIFEVEST. THE PATIENT RECEIVED FOUR INAPPROPRIATE TREATMENTS. THE DEVICE WAS STARTED UP AT 12:08:06 ON (B)(6) 2025. AT 19:15:41, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS AF WITH RVR @ 220 BPM WITH NSVT. AT 19:16:17, THE PATIENT RECEIVED THE FIRST INAPPROPRIATE TREATMENT. AF WITH RVR AND NSVT CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS AF WITH RVR @ 220 BPM WITH NSVT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 120 BPM WITH PVC¿S. AT 19:34:44, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS AF WITH RVR @ 230 BPM. AT 19:35:41, THE PATIENT RECEIVED THE SECOND INAPPROPRIATE TREATMENT. AF WITH RVR AND NSVT CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS AF WITH RVR @ 220 BPM WITH NSVT. POST SHOCK RHYTHM WAS SINUS RHYTHM @ 90 BPM WITH PAC¿S AND PVC¿S. AT 19:38:57, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS AF WITH RVR @ 180 BPM. AT 19:39:57, THE PATIENT RECEIVED THE THIRD INAPPROPRIATE TREATMENT. AF WITH RVR AND NSVT CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS AF WITH RVR @ 190 BPM WITH NSVT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 120 BPM WITH PVC¿S. AT 19:48:36, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS AF WITH RVR @ 170 BPM. AT 19:49:16, THE PATIENT RECEIVED THE FOURTH INAPPROPRIATE TREATMENT. AF WITH RVR AND NSVT CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS AF WITH RVR @ 180 BPM WITH NSVT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S. THE DEVICE WAS SHUT DOWN AT 21:07:30 ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254993 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death