BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10302094 · Received July 21, 2020

    Report

    Report Number
    3008642652-2020-06233
    Event Type
    Death
    Date Received
    July 21, 2020
    Date of Event
    June 20, 2020
    Report Date
    July 21, 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) AND ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. 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 MANUFACTURER DATE: MONITOR: 08/06/2015, ELECTRODE BELT: 06/10/2013.

    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) 2020. THE PATIENT WAS UNCONSCIOUS AT THE TIME OF PASSING. IT WAS REPORTED THAT THE PATIENT BECAME DIZZY AND LOST CONSCIOUSNESS. IT WAS ALSO REPORTED THAT EMS ATTEMPTED TO RESUSCITATE THE PATIENT. REVIEW OF THE DOWNLOAD DATA, INDICATES THE PATIENT RECEIVED ONE SHOCK IN RESPONSE TO CPR ARTIFACT. THE PATIENT WAS IN CPR ARTIFACT AT THE TIME OF THE TREATMENT SHOCK AT 20:36:53. THE PATIENT'S POST SHOCK RHYTHM WAS CPR ARTIFACT WITH ECG INTERFERENCE/DISCONNECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THE PATIENT PASSED AWAY ON (B)(6) 2020 AT APPROXIMATELY 9:00PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767495 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death