BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 23217218 · Received October 4, 2025

    Report

    Report Number
    3008642652-2025-09535
    Event Type
    Death
    Date Received
    October 4, 2025
    Date of Event
    May 4, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    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 HAS BEEN COMPLETED. 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. THE ELECTRODE BELT HAS BEEN RETURNED AND THE EVALUATION IS UNDERWAY. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD DOES NOT INDICATE ANY DEVICE 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 FIVE INAPPROPRIATE TREATMENTS. THE DEVICE WAS STARTED UP AT 20:28:12 ON (B)(6) 2025. AT 21:05:04, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SINUS TACHYCARDIA @ 115 BPM WITH PAC¿S, PVC¿S AND NSVT. AT 21:05:41, THE PATIENT RECEIVED THE FIRST INAPPROPRIATE TREATMENT. NSVT AND MULTIPLE COUNTING CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS SINUS RHYTHM @ 80 BPM WITH PAC¿S, PVC¿S AND NSVT. POST SHOCK RHYTHM WAS SINUS RHYTHM @ 70 BPM WITH PAC¿S, PVC¿S AND NSVT. AT 21:09:00, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SINUS TACHYCARDIA @ 110 BPM WITH TALL T WAVES, AND PVC¿S. AT 21:09:43, THE PATIENT RECEIVED THE SECOND INAPPROPRIATE TREATMENT. NSVT AND MULTIPLE COUNTING CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS SINUS TACHYCARDIA @ 130 BPM WITH TALL T WAVES, AND PVC¿S. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 130 BPM WITH TALL T WAVES, AND PVC¿S. AT 21:10:37, THE PATIENT RECEIVED THE THIRD INAPPROPRIATE TREATMENT. NSVT AND MULTIPLE COUNTING CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS NSVT. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 120 BPM WITH PAC¿S, AND PVC¿S. AT 21:11:23, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SINUS TACHYCARDIA @ 110 BPM WITH PVC¿S AND NSVT. AT 21:12:05, THE PATIENT RECEIVED THE FOURTH INAPPROPRIATE TREATMENT. NSVT AND MULTIPLE COUNTING CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS SINUS TACHYCARDIA @ 130 BPM WITH PAC¿S, AND PVC¿S. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 130 BPM WITH PAC¿S, AND PVC¿S. AT 21:13:29, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SINUS RHYTHM @ 70 BPM WITH PVC¿S AND NSVT. AT 21:14:13, THE PATIENT RECEIVED THE FIFTH INAPPROPRIATE TREATMENT. NSVT AND MULTIPLE COUNTING CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS SINUS RHYTHM @ 80 BPM WITH PVC¿S. POST SHOCK RHYTHM WAS SINUS RHYTHM @ 80 BPM WITH PAC¿S AND PVC¿S. THE ELECTRODE BELT WAS DISCONNECTED AT 21:20:41 ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2652972 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death