BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 12443477 · Received September 8, 2021

    Report

    Report Number
    3008642652-2021-07770
    Event Type
    Death
    Date Received
    September 8, 2021
    Date of Event
    June 6, 2021
    Report Date
    September 8, 2021
    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

    THE MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WERE RETURNED AND EVALUATED AT THE DISTRIBUTOR. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION. 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 · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2021 WHILE WEARING THE LIFEVEST. REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALS THAT PRIOR TO PASSING, THE PATIENT RECEIVED ONE APPROPRIATE AND ONE INAPPROPRIATE TREATMENT FROM THE LIFEVEST. AT 14:29:21, THE PATIENT RECEIVED THE FIRST TREATMENT FROM THE LIFEVEST. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS VF, AND THE POST-SHOCK RHYTHM WAS FIVE SECONDS OF ASYSTOLE TRANSITIONING TO AN IDIOVENTRICULAR RHYTHM AT 70 BPM. AT 14:30:10, THE PATIENTS RECEIVED THE SECOND TREATMENT FROM THE LIFEVEST. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS AN IDIOVENTRICULAR RHYTHM AT 80 BPM, AND THE POST-SHOCK RHYTHM WAS ALSO AN IDIOVENTRICULAR RHYTHM AT 80 BPM. OVERSENSING OF LOW AMPLITUDE CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT'S RHYTHM THEN DEGRADED TO ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. THE PATIENT'S REMAINED IN ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY UNTIL THE ELECTRODE BELT WAS DISCONNECTED AT 14:51:24. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING. THE EQUIPMENT WAS RETURNED AND WAS FOUND TO BE FULLY FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334756 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death