BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9362794 · Received November 22, 2019

    Report

    Report Number
    3008642652-2019-09473
    Event Type
    Death
    Date Received
    November 22, 2019
    Date of Event
    October 12, 2019
    Report Date
    November 21, 2019
    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 ELECTRODE BELT SN (B)(4) WERE RETURNED AND EVALUATED AT THE DISTRIBUTOR, IN ACCORDANCE WITH PROCEDURES RECOMMENDED BY ZOLL MANUFACTURING CORPORATION. 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 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 OF THE DEVICE. DEVICE MANUFACTURE DATE: MONITOR: 9/14/2017, BELT: 11/25/2013.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY WHILE WEARING THE LIFEVEST ON (B)(6) 2019. THE PATIENT WAS AT A NURSING FACILITY AT THE TIME OF PASSING. REVIEW OF THE DOWNLOAD DATA, INDICATES THE PATIENT RECEIVED FOUR SHOCKS IN RESPONSE TO OVERSENSING OF LOW CARDIAC SIGNAL. THE PATIENT WAS IN ASYSTOLE WITH CPR/MOTION ARTIFACT AT THE TIME OF ALL FOUR TREATMENT SHOCKS AT 17:48:32, 17:48:56, 17:54:34 AND 17:55:21. THE PATIENT'S POST SHOCK RHYTHM FOR THE FIRST THREE SHOCKS WAS ASYSTOLE WITH CPR/MOTION ARTIFACT. THE PATIENT'S POST SHOCK RHYTHM FOR THE FOURTH TREATMENT WAS ASYSTOLE WITH CPR/MOTION ARTIFACT AND CARDIAC ACTIVITY. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THE PATIENT PASSED AWAY ON (B)(6) 2019. THERE IS NO INDICATION THAT THE LIFEVEST TREATMENTS DURING ASYSTOLE CAUSED OR CONTRIBUTED TO THE DEATH AS, THE PATIENT WAS ALREADY IN A NON-LIFE-SUSTAINING RHYTHM. NO DEFICIENCIES WERE ALLEGED AGAINST THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160029 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death