BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6136613 · Received November 30, 2016

    Report

    Report Number
    3008642652-2016-08769
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    October 21, 2016
    Report Date
    November 1, 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 SUMMARY: MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WERE RETURNED AND EVALUATED AT THE DISTRIBUTOR, IN ACCORDANCE WITH PROCEDURES RECOMMENDED BY ZOLL MANUFACTURING CORPORATION. THE REPORTED PROBLEM (PATIENT DEATH/TREATMENT) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL AND PASSED INCOMING FUNCTIONALITY 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 OF THE DEVICE. DEVICE MANUFACTURE DATE: MONITOR: SN (B)(4): 11/26/2014 REUSE, ELECTRODE BELT: SN (B)(4): 05/13/2014 REUSE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR NOTIFIED ZOLL THAT A PATIENT PASSED AWAY ON (B)(6) 2016. PRIOR TO PASSING, THE PATIENT RECEIVED AN INAPPROPRIATE DEFIBRILLATION ON (B)(6) 2016. THE PATIENT WAS NOT CONSCIOUS AT THE TIME OF THE INAPPROPRIATE TREATMENT. ON (B)(6) 2016 AT 17:32:42 THE PATIENT WAS IN VENTRICULAR FIBRILLATION (VF) PRIOR TO SELF-CONVERTING TO ASYSTOLE 8 SECONDS BEFORE THE TREATMENT WAS DELIVERED. THE POST-SHOCK RHYTHM WAS ASYSTOLE. ASYSTOLE IS CONSIDERED A NON-SHOCKABLE RHYTHM. CPR ARTIFACT AND RESPONSE BUTTON USE INDICATES THE PRESENCE OF BYSTANDERS. THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT WAS DELIVERED. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. THE DEVICE WAS SHUT DOWN ON (B)(6) 2016 AT 17:43:52. THE PATIENT'S RHYTHM PRIOR TO DEVICE SHUTDOWN WAS ASYSTOLE WITH CPR ARTIFACT. THE PATIENT PASSED AWAY ON (B)(6) 2016 IN THE HOSPITAL. THERE IS NO EVIDENCE TO SUGGEST THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH, AS THE PATIENT WAS ALREADY IN A NON-TREATABLE, NON-LIFE SUSTAINING RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785017 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death