BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 16499161 · Received March 7, 2023

    Report

    Report Number
    3008642652-2023-02185
    Event Type
    Death
    Date Received
    March 7, 2023
    Date of Event
    December 13, 2022
    Report Date
    March 6, 2023
    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 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) 2022 WHILE REPORTEDLY WEARING THE LIFEVEST. THE PATIENT RECEIVED TWO INAPPROPRIATE TREATMENTS. THE DEVICE WAS STARTED UP AT 12:06:43 ON 12/12/2022. AT 05:32:51 ON (B)(6) 2022, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SVT @ 160 BPM WITH PVC¿S, MOTION ARTIFACT, AND ELECTRODE LEAD FALL OFF. AT 05:34:01, THE PATIENT RECEIVED THE FIRST INAPPROPRIATE TREATMENT. SVT CONTRIBUTED TO THE FALSE DETECTION. THE RHYTHM AT THE TIME OF TREATMENT WAS SVT @ 150 BPM WITH PVC¿S, MOTION ARTIFACT, AND ELECTRODE LEAD FALL OFF. POST SHOCK RHYTHM WAS SVT @ 160 BPM WITH PVC¿S, MOTION ARTIFACT, AND ELECTRODE LEAD FALL OFF. AT 05:34:25 THE PATIENT RECEIVED THE SECOND INAPPROPRIATE TREATMENT. SVT CONTRIBUTED TO THE FALSE DETECTION. THE RHYTHM AT THE TIME OF TREATMENT WAS SVT @ 150 BPM WITH PVC¿S, MOTION ARTIFACT, AND ELECTRODE LEAD FALL OFF. POST SHOCK RHYTHM WAS SVT @ 160 BPM WITH PVC¿S, MOTION ARTIFACT, AND ELECTRODE LEAD FALL OFF. THE ELECTRODE BELT WAS DISCONNECTED AT 07:15:25 ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626602 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death