BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 12219741 · Received July 23, 2021

    Report

    Report Number
    3008642652-2021-06355
    Event Type
    Death
    Date Received
    July 23, 2021
    Date of Event
    June 16, 2021
    Report Date
    July 22, 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

    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 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. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE ELECTRODE BELT ECG "C&D" CABLE WAS CUT, DAMAGING WIRES IN THE CABLE. THERE IS NO INDICATION THE DAMAGED BELT CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING. THE DEVICE WAS ABLE TO RECORD THE PATIENT'S ECG RHYTHM THROUGHOUT THE EVENT. THE ROOT CAUSE FOR CUT CABLE WAS PHYSICAL ABUSE. DEVICE MANUFACTURE DATE: MONITOR: 03/17/2021. BELT: 04/23/2021.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY IN THE HOSPITAL AT 13:21 ON (B)6) 2021. IT WAS REPORTED THAT THE PATIENT WAS IN A REHAB FACILITY AND WAS TREATED BY THE LIFEVEST ON (B)(6) 2021. THE PATIENT WAS THEN TRANSFERRED TO A HOSPITAL WHERE THEY PASSED AWAY WHILE NOT WEARING THE LIFEVEST. REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALED THAT THE PATIENT RECEIVED ONE APPROPRIATE TREATMENT AND ONE INAPPROPRIATE TREATMENT ON THE DATE OF PASSING IN RESPONSE TO OVERSENSING OF LOW AMPLITUDE CARDIAC SIGNAL AND CPR/MOTION ARTIFACT. THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 90 BPM AT 09:55:51 ON (B)(6) 2021. THE PATIENT'S RHYTHM TRANSITIONED TO VT AT 130 BPM AT 10:07:32. THE PATIENT RECEIVED THE APPROPRIATE TREATMENT AT 10:08:45. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS VT AT 130 BPM. THE PATIENT'S POST-SHOCK RHYTHM WAS SINUS RHYTHM AT 60 BPM WITH MOTION ARTIFACT. THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 12:35:27. BETWEEN 12:36:31 AND 12:41:03, THE PATIENT'S IDIOVENTRICULAR RHYTHM DEGRADED TO ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. THE PATIENT'S RHYTHM THEN TRANSITIONED TO VT AT 150 BPM AT 12:41:44 BEFORE DEGRADING BACK TO ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. THE PATIENT RECEIVED THE INAPPROPRIATE TREATMENT AT 12:43:40. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS ASYSTOLE WITH CPR/MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE WITH CPR/MOTION ARTIFACT WHICH TRANSITIONED TO AN IDIOVENTRICULAR RHYTHM AT 20 BPM. THE PATIENT'S RHYTHM WAS OBSCURED BY CPR/MOTION ARTIFACT AT THE TIME OF THE DEVICE SHUTDOWN AT 12:58:04 ON (B)(6) 2021. THE PATIENT PASSED AWAY IN THE HOSPITAL AT 13:21 WHILE NOT WEARING THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113441 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death