BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10167304 · Received June 18, 2020

    Report

    Report Number
    3008642652-2020-05299
    Event Type
    Death
    Date Received
    June 18, 2020
    Date of Event
    March 12, 2019
    Report Date
    June 17, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR WAS FULLY FUNCTIONAL AND PASSED INCOMING FUNCTIONAL TESTING. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE DEVICE, 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 MONITOR. ELECTRODE BELT SN (B)(4) HAS NOT YET BEEN RECOVERED 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 DEATH. DEVICE MANUFACTURER DATE: MONITOR: 04/25/2012, ELECTRODE BELT: 09/01/2015.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2019 AT 10:24AM, WHILE WEARING THE LIFEVEST. THE PATIENT'S WIFE WAS PRESENT AT THE TIME OF PASSING. THE PATIENT'S WIFE REPORTS THAT THE PATIENT EXPERIENCED A SEIZURE AND SOPPED BREATHING. IT WAS REPORTED THAT THE LIFEVEST WAS NOT ALARMING. IT WAS REPORTED THAT RESUSCITATION EFFORTS WERE ATTEMPTED. PER CLINICAL REVIEW OF THE AVAILABLE ECG DATA, THE PATIENT WAS IN BRADYCARDIA STATUS AT 30 BPM WITH CPR ARTIFACT. THE RHYTHM THEN DEGRADES TO VENTRICULAR FIBRILLATION (VF) WITH CPR ARTIFACT. THE PATIENT WAS SEEN IN VF FOR 14 SECONDS FROM 10:09:32 TO 10:09:46 BEFORE CPR WAS RESUMED. CPR ARTIFACT/MOTION ARTIFACT/PACER SPIKES WAS SEEN FROM 10:09:46 UNTIL THE ELECTRODE BELT WAS DISCONNECTED AT 10:12:55 ON (B)(6) 2019. CPR/MOTION ARTIFACT PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT. IT WAS REPORTED THAT SOMEONE PERFORMED RESUSCITATION EFFORTS, IT IS UNCLEAR IF IT WAS A HEALTH PROFESSIONAL. THE PATIENT'S MONITOR WAS RETURNED AND WAS FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632714 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death