BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6472065 · Received April 7, 2017

    Report

    Report Number
    3008642652-2017-02936
    Event Type
    Death
    Date Received
    April 7, 2017
    Date of Event
    February 11, 2017
    Report Date
    April 6, 2017
    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

    ELECTRODE BELT SN (B)(4) AND MONITOR SN (B)(4) WERE RETURNED AND EVALUATED AT 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 PATIENT DEATH. DURING THE INCOMING FUNCTIONAL TESTING, A 1 HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5 HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5 HZ 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 DEVICE MALFUNCTION. DEVICE MANUFACTURE DATE: MONITOR: SN (B)(4): 04/25/2013 REUSE, ELECTRODE BELT: SN (B)(4): 09/14/2015 REUSE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2017. THE PATIENT WAS AT HOME AT THE TIME OF PASSING. THE PATIENT'S WIFE REPORTED THAT SHE FOUND THE PATIENT UNCONSCIOUS ON THE BEDROOM FLOOR. THE PATIENT PASSED AWAY AT 04:36 ON (B)(6) 2017. A REVIEW OF DEVICE DOWNLOAD DATA REVEALS THAT THE PATIENT WAS TREATED 7 TIMES ON (B)(6) 2017. THE FIRST 5 TREATMENTS WERE DELIVERED BETWEEN 02:02:38 AND 02:04:27. THE LIFEVEST FIRST DETECTED AN ARRHYTHMIA AT 02:02:03. THE ECG RECORDINGS SHOW THAT THE PATIENT WAS IN VENTRICULAR FIBRILLATION (VF). THE RHYTHM AT THE TIME OF THE FIRST TREATMENT WAS VF. THE POST-SHOCK RHYTHM REMAINED VF. TREATMENTS 2-5 WERE ALL DELIVERED DURING VF, BUT WERE UNABLE TO CONVERT THE RHYTHM FROM VF. THE POST-SHOCK RHYTHM OF THE FIFTH TREATMENT WAS VF DEGRADING TO ASYSTOLE. ASYSTOLE IS CONSIDERED A NON-SHOCKABLE RHYTHM. TREATMENTS 6 AND 7 WERE DELIVERED BETWEEN 04:15:28 AND 04:16:10. TREATMENT SHOCK 6 WAS DELIVERED WHILE THE PATIENT WAS IN ASYSTOLE. THE ECG RECORDINGS SHOW A POST-SHOCK RHYTHM OF CPR ARTIFACT. THE RHYTHM AT THE TIME OF TREATMENT SHOCK 7 WAS CPR ARTIFACT. THE POST-SHOCK RHYTHM WAS CPR ARTIFACT. CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTIONS. THE RESPONSE BUTTONS WERE PRESSED AFTER TREATMENT SHOCK 7. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. CPR ARTIFACT AND THE RESPONSE BUTTONS BEING PRESSED INDICATE THE PRESENCE OF BYSTANDERS. THE DEVICE WAS SHUTDOWN AT 05:09:05. THE ECG RECORDING SHOWS CPR ARTIFACT AT THE TIME OF THE DEVICE SHUTDOWN. PER THE FLAGS, TREATMENT SHOCKS 6 AND 7 WERE FULL ENERGY TREATMENTS (150J). TREATMENT SHOCKS 1-5 WERE FOUND TO BE LOW ENERGY PULSES BETWEEN 140J AND 145J. TREATMENT SHOCK 1 WAS 145J, TREATMENT SHOCK 2 WAS 140J, TREATMENT SHOCK 3 WAS 141J, AND TREATMENT SHOCKS 4 AND 5 WERE 140J. REVIEW OF THE FLAGS INDICATES THAT THE THERAPY ELECTRODES HAD POOR CONTACT WITH THE PATIENT'S SKIN. THE POOR THERAPY ELECTRODE CONTACT RESULTED IN A HIGH-IMPEDANCE CONDITION THAT CAUSED THE LOW ENERGY PULSES. THE THERAPY ELECTRODES RELEASED GEL CORRECTLY, BUT DUE TO THE POOR CONTACT THE IMPEDANCE REMAINED HIGH WHEN FIRING THE PULSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255914 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death