BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6031216 · Received October 14, 2016

    Report

    Report Number
    3008642652-2016-07436
    Event Type
    Death
    Date Received
    October 14, 2016
    Date of Event
    September 3, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    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 (B)(4) AND ELECTRODE BELT (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.

    Description of Event or Problem · 1

    A DISTRIBUTOR CONTACTED ZOLL TO REPORT A PATIENT DEATH. THE PATIENT PASSED AWAY ON (B)(6) 2016 AT APPROXIMATELY 03:45 AM WHILE IN THE HOSPITAL. A REVIEW OF DOWNLOAD DATA SHOWS THE LIFEVEST DETECTED AN ARRHYTHMIA AT 03:07:30 ON (B)(6) 2016. THE PATIENT WAS IN ATRIAL FIBRILLATION DEGRADING TO VF. THE LIFEVEST PROPERLY DETECTED A VENTRICULAR ARRYTHMIA. THE LIFEVEST WAS SHUTDOWN AT 03:08:21 WHILE THE PATIENT WAS IN VF. THE HOSPITAL STAFF DEACTIVATED THE LIFEVEST DURING THE TREATMENT SEQUENCE AND BEFORE A SHOCK COULD BE DELIVERED. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THERE IS NO ALLEGED DEFICIENCY AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682655 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death