BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 15643130 · Received October 20, 2022

    Report

    Report Number
    3008642652-2022-24729
    Event Type
    Death
    Date Received
    October 20, 2022
    Date of Event
    August 11, 2022
    Report Date
    October 3, 2022
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    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 WAS RETURNED FOR INVESTIGATION AND DID NOT PASS INCOMING FUNCTIONAL TESTING FOR ECG FALL-OFF. THE CABLE CONNECTING ECG "A" AND ECG "B" WAS PULLED FROM THE STRAIN RELIEF, RESULTING IN THE J500 CONNECTOR BEING BROKEN FROM THE BELT NODE. THE ROOT CAUSE FOR THE STRAINED CABLE WAS EXCESSIVE FORCE. THERE IS NO INDICATION THE PULLED STRAINED CABLE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH AS THE SYSTEM WAS ABLE TO DETECT CARDIAC RHYTHM ON THE DATE OF EVENT.

    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 AN INAPPROPRIATE TREATMENT.   THE DEVICE WAS STARTED UP AT 17:01:43 ON (B)(6) 2022. AT 17:03:09, AN ARRHYTHMIA WAS DETECTED. PER REVIEW OF THE HOLTER DATA, THE PATIENT WAS IN ASYSTOLE WITH MOTION ARTIFACT. AT 17:04:19, THE PATIENT RECEIVED THE INAPPROPRIATE TREATMENT. OVERSENSING OF CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT WAS IN A NON-LIFE SUSTAINING RHYTHM PRIOR TO THE SHOCK. THE RHYTHM AT THE TIME OF TREATMENT WAS ASYSTOLE WITH MOTION ARTIFACT. THE POST SHOCK RHYTHM WAS OBSCURED DUE TO MOTION ARTIFACT AND ELECTRODE LEAD FALLOFF. THE DEVICE WAS SHUT DOWN AT 17:52:56 ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307591 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death