BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11794383 · Received May 7, 2021

    Report

    Report Number
    3008642652-2021-03942
    Event Type
    Death
    Date Received
    May 7, 2021
    Date of Event
    March 24, 2021
    Report Date
    May 6, 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. THE ELECTRODE BELT HAS NOT BEEN RECOVERED. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD (04/14/2021) DOES NOT INDICATE ANY DEVICE MALFUNCTION. THE REVIEW OF THE DATA INDICATED THAT THE DEVICE POWERED ON NORMALLY AND WAS ABLE TO ACQUIRE THE PATIENT'S ECG SIGNAL ON THE LAST DAY OF USE CAPTURED IN THE DATA DOWNLOAD. NO DEFICIENCIES ALLEGED. DEVICE MANUFACTURE DATE: MONITOR 07/22/2014; BELT 08/14/2020.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY IN THE HOSPITAL ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT'S LIFEVEST WAS REMOVED BY THE HOSPITAL PRIOR TO THEIR PASSING ON (B)(6) 2021. PER CLINICAL REVIEW OF THE CONTINUOUS ECG RECORDINGS, THE DEVICE WAS STARTED UP AT 12:58:05 ON (B)(6) 2021. THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 07:13:47 ON (B)(6) 2021. CPR/MOTION ARTIFACT BEGAN AT 07:17:58. THE PATIENT'S RHYTHM TRANSITIONED TO VT AT 150 BPM AT 07:24:21. THE PATIENT RECEIVED THE FIRST NON-LIFEVEST DEFIBRILLATION AT 07:24:54. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT AND POST-SHOCK RHYTHM WERE VT AT 170 BPM. THE LIFEVEST DETECTED AN ARRHYTHMIA AT 07:25:02 WHILE THE PATIENT WAS IN VT AT 170 BPM. THE PATIENT RECEIVED THE SECOND NON-LIFEVEST DEFIBRILLATION AT 07:25:22. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT AND POST-SHOCK RHYTHM WERE VT AT 170 BPM. CPR/MOTION ARTIFACT AND RESPONSE BUTTON USE OCCURRED AFTER THE SECOND NON-LIFEVEST DEFIBRILLATION, PREVENTING THE LIFEVEST FROM DELIVERING A TREATMENT. IT WAS NOT REPORTED WHO WAS PRESSING THE RESPONSE BUTTONS. THE LIFEVEST DETECTED AN ARRHYTHMIA AT 07:26:31 WHILE THE PATIENT WAS IN VT AT 170 BPM WITH CPR/MOTION ARTIFACT. CPR/MOTION ARTIFACT PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT. THE PATIENT RECEIVED A THIRD NON-LIFEVEST DEFIBRILLATION AT 07:27:03. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT AND POST-SHOCK RHYTHM WERE VT AT 170 BPM. THE DEVICE WAS SHUTDOWN AT 07:45:58 ON (B)(6) 2021 WHILE THE PATIENT WAS IN VT AT 140 BPM WITH CPR/MOTION ARTIFACT. THE PATIENT PASSED AWAY IN THE HOSPITAL ON (B)(6) 2021. REPORTING EVENT DUE TO BYSTANDER INTERFERENCE PREVENTING THE LIFEVEST FROM TREATING THE PATIENT FOLLOWING ARRHYTHMIA DETECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684781 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death