BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9670493 · Received February 5, 2020

    Report

    Report Number
    3008642652-2020-00799
    Event Type
    Death
    Date Received
    February 5, 2020
    Date of Event
    December 12, 2019
    Report Date
    February 3, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE MONITOR, 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 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 MONITOR MALFUNCTION. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) HAS BEEN INVESTIGATED. UPON INVESTIGATION THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO THE REAR THERAPY ELECTRODES WAS PULLED FROM THE STRAIN RELIEF, DAMAGING WIRES IN THE CABLE. IT WAS REPORTED THAT CPR WAS PERFORMED ON THE PATIENT WHILE THEY WERE WEARING THE LIFEVEST, AND CPR ARTIFACT WAS PRESENT IN THE PATIENT'S CONTINUOUS ECG RECORDINGS UNTIL THE ELECTRODE BELT WAS DISCONNECTED. THE ROOT CAUSE FOR THE STRAINED CABLE WAS EXCESSIVE FORCE. DEVICE MANUFACTURE DATE: MONITOR: 10/04/2012, BELT: 11/05/2014.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT WAS TAKEN FROM THEIR HOME TO THE HOSPITAL BY EMS AND PASSED AWAY SHORTLY AFTER ARRIVING AT THE HOSPITAL. THE PATIENT'S CONTINUOUS ECG RECORDINGS SHOW THAT FOLLOWING DEVICE STARTUP AT 10:12:58 ON (B)(6) 2019, NOISE IN THE FRONT TO BACK AND SIDE TO SIDE CHANNELS AND BRADYCARDIA WERE DETECTED INTERMITTENTLY FROM 13:56:52 ON (B)(6) 2019 TO 07:33:16 ON (B)(6) 2019. THE ELECTRODE BELT WAS DISCONNECTED AT 7:33:16. PER THE CONTINUOUS ECG RECORDINGS, THE PATIENT WAS IN SINUS BRADYCARDIA AT 40 BPM SLOWING TO SINUS BRADYCARDIA AT 30 BPM WITH CPR/MOTION ARTIFACT. THE PATIENT'S RHYTHM THEN DEGRADED TO VENTRICULAR TACHYCARDIA (VT) WITH CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALLOFF FROM APPROXIMATELY 06:57:30 UNTIL THE ELECTRODE BELT DISCONNECTION. THE PATIENT WAS SEEN IN VT FOR ONE MINUTE AND EIGHT SECONDS. CPR/MOTION ARTIFACT PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT WHILE THE PATIENT WAS IN VT. IT WAS REPORTED THAT CPR WAS PERFORMED BY HOSPITAL STAFF. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING. WHILE INVESTIGATING THE PATIENT'S ELECTRODE BELT, A REPORTABLE MALFUNCTION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134438 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death