BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 14690903 · Received June 14, 2022

    Report

    Report Number
    3008642652-2022-05477
    Event Type
    Death
    Date Received
    June 14, 2022
    Date of Event
    April 14, 2022
    Report Date
    June 6, 2022
    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. THE PATIENT RECEIVED TWO INAPPROPRIATE TREATMENTS.   THE DEVICE WAS STARTED UP AT 16:10:56 ON (B)(6) 2022. AT 00:06:48 ON (B)(6) 2022, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SVT @ 160 BPM WITH PVC'S, MOTION ARTIFACT, AND VARYING AMPLITUDES. AT 00:08:08, THE PATIENT RECEIVED THE FIRST INAPPROPRIATE TREATMENT. THE RHYTHM AT TIME OF TREATMENT WAS SVT @ 160 BPM WITH PVC'S, MOTION ARTIFACT, AND VARYING AMPLITUDES. POST SHOCK RHYTHM WAS SVT @ 160 BPM WITH PVC'S, MOTION ARTIFACT, AND VARYING AMPLITUDES. AT 00:08:43, THE PATIENT RECEIVED THE SECOND INAPPROPRIATE TREATMENT. THE RHYTHM AT TIME OF TREATMENT WAS SVT @ 160 BPM WITH PVC'S, MOTION ARTIFACT, AND VARYING AMPLITUDES. POST SHOCK RHYTHM WAS SVT @ 160 BPM WITH PVC'S, MOTION ARTIFACT, AND VARYING AMPLITUDES. THE DEVICE WAS SHUT DOWN AT 00:16:27 ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628792 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death