BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10701454 · Received October 19, 2020

    Report

    Report Number
    3008642652-2018-08464
    Event Type
    Death
    Date Received
    October 19, 2020
    Date of Event
    August 30, 2018
    Report Date
    August 8, 2018
    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

    MONITOR SN (B)(4) AND BELT SN (B)(4) WERE RETURNED AND EVALUATED AT ZOLL MANUFACTURING CORPORATION. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES (ATTACHED) 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 THAT WOULD CONTRIBUTE TO THE INAPPROPRIATE TREATMENT. 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.

    Description of Event or Problem · 1

    ON 10/16/2020: RESUBMITTING THIS MDR AS PART OF AN INTERNAL AUDIT WHERE THE ELECTRONIC 3500A PDF FORM COULD NOT BE LOCATED. THE INTERNAL AUDIT INDICATES THAT THE ELECTRONIC 3500A FORM, WITHIN THE ESUBMITTER APPLICATION, WAS CREATED ON 09/28/2018. ACKNOWLEDGEMENTS 1, 2, AND 3 COULD NOT BE LOCATED. A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY WHILE WEARING THE LIFEVEST. THE PATIENT WAS REPORTEDLY IN A HOSPITAL AT THE TIME OF THE EVENT. REVIEW OF THE DOWNLOAD DATA INDICATES THAT THE PATIENT ENTERED ASYSTOLE AND RECEIVED TWO SHOCKS PRIOR TO PASSING. OVERSENSING A LOW AMPLITUDE CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. ASYSTOLE IS CONSIDERED A NON-LIFE SUSTAINING RHYTHM. THE ELECTRODE BELT WAS DISCONNECTED AND THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159871 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| O