BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5605739 · Received April 25, 2016

    Report

    Report Number
    3008642652-2016-02678
    Event Type
    Death
    Date Received
    April 25, 2016
    Date of Event
    April 1, 2016
    Report Date
    April 20, 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 EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. 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 DEATH. 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. DEVICE MANUFACTURE DATE: MONITOR: SN (B)(4): 07/23/2013 REUSE, ELECTRODE BELT: SN (B)(4): 06/11/2013 REUSE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR REPORTED THAT A PATIENT PASSED AWAY ON (B)(6) 2016 AFTER RECEIVING A TREATMENT EVENT CONSISTING OF FOUR SHOCKS. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL AND WAS UNCONSCIOUS DURING THE TREATMENT EVENT. IT WAS REPORTED THAT HOSPITAL STAFF MEMBERS WERE PRESENT DURING THE TREATMENT EVENT AND REMOVED THE LIFEVEST AFTER SHOCK FOUR. THE PATIENT RECEIVED FOUR SHOCKS FROM 14:27:11 TO 14:28:24. THE PATIENT'S RHYTHM AT THE TIME OF EACH SHOCK WAS ATRIAL FIBRILLATION. A NON-TREATABLE RHYTHM WAS DETECTED AT 14:28:42, AND THE ELECTRODE BELT WAS DISCONNECTED AT 14:29:19. IT WAS REPORTED THAT THE LIFEVEST WAS REMOVED AND THE PATIENT WAS INTUBATED FOLLOWING THE FOURTH SHOCK. THE PATIENT PASSED AWAY LATER THAT DAY ((B)(6) 2016) BETWEEN 14:30 AND 16:30 WHILE NOT WEARING THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261396 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| O