BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5152539 · Received October 15, 2015

    Report

    Report Number
    3008642652-2015-05897
    Event Type
    Death
    Date Received
    October 15, 2015
    Date of Event
    July 7, 2015
    Report Date
    October 13, 2015
    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

    THE MONITOR SN (B)(4) AND 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 INAPPROPRIATE TREATMENT. 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: 08/21/2012, ELECTRODE BELT: 05/25/2012.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL ON (B)(6) 2015 TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2015. THE PATIENT WAS IN A HOSPITAL AT THE TIME OF PASSING. THE PATIENT DIED WHILE WEARING THE LIFEVEST AND NURSES WERE PERFORMING RESUSCITATION EFFORTS. IT WAS REPORTED THAT THE PATIENT WAS TREATED AND THAT HOSPITAL STAFF WERE ALSO SHOCKED AS THEY WERE PERFORMING CPR. THERE WAS NO REPORT OF ANY INJURY TO THE HOSPITAL STAFF. PER REVIEW OF THE EVENT, THE PATIENT RECEIVED TWO INAPPROPRIATE DEFIBRILLATIONS BETWEEN 04:11:00 AND 04:11:42AM ON (B)(6) 2015. THE RHYTHM AT THE TIME OF BOTH SHOCKS WAS ASYSTOLE WITH CPR ARTIFACT. CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. PRIOR TO THE TREATMENTS, ASYSTOLE WAS DETECTED AND ALARMED FOR 11 TIMES BETWEEN 04:01:46 AND 04:09:32AM. ASYSTOLE IS CONSIDERED A NON-LIFE SUSTAINING, NON-TREATABLE RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683666 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death