BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11058182 · Received December 22, 2020

    Report

    Report Number
    3008642652-2020-11443
    Event Type
    Death
    Date Received
    December 22, 2020
    Date of Event
    November 22, 2020
    Report Date
    December 22, 2020
    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

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE MONITOR, 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 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. ELECTRODE BELT SN (B)(4) HAS NOT YET RETURNED FROM THE FIELD. DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. 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 PATIENT'S PASSING. MANUFACTURE DATES: MONITOR 9/23/2016, ELECTRODE BELT 6/25/2012.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2020 WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT THE PATIENT WAS TAKING A NAP PRIOR TO PASSING. CLINICAL REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALED THAT PRIOR TO PASSING, THE PATIENT RECEIVED AN APPROPRIATE TREATMENT FROM THE LIFEVEST. AT 10:26:51 AM, THE LIFEVEST DETECTED AN ARRHYTHMIA. THE PATIENT'S RHYHTM AT THIS TIME WAS SINUS RHYTHM AT 70 BPM DEGRADING TO VENTRICULAR FIBRILLATION (VF) WITH MOITON ARTIFACT. THE PATIENT IS ALSO SEEN IN VF WITH MOTION ARTIFACT AT 10:27:59 AM. AT 10:28:10, THE PATIENT RECEIVED AN APPROPRIATE TREATMENT FROM THE LIFEVEST DURING VF. THE RHYTHM WAS CONVERTED TO SINUS BRADYCARDIA AT 20-30 BPM WITH HEART BLOCK. MOTION ARTIFACT PREVENTED THE LIFEVEST FROM DELIVERING AN APPROPRIATE TREATMENT FROM 10:26:51 AM UNTIL THE TREATMENT WAS DELIVERED AT 10:28:10 AM. BRADYCARDIA WAS DETECTED BY THE LIFEVEST FROM 10:30:58 AM TO 10:43:01 AM. FROM 10:52:27 TO 11:08:31 AM, THE PATIENT'S RHYTHM WAS IDIOVENTRICULAR RHYTHM AT 30 BPM SLOWING TO AN IDIOVENTRICULAR RHYTHM AT 10 BPM DEGRADING TO ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. THE RHYTHM THEN DEGRADED TO ASYSTOLE. THE ELECTRODE BELT WAS DISCONNECTED AT 11:10:51 AM WHILE THE PATIENT'S RHYTHM WAS ASYSTOLE. REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION AS THE APPROPRIATE TREATMENT WAS DELAYED DUE TO MOTION ARTIFACT PRIOR TO THE PATIENT'S PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522814 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O