BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8578962 · Received May 3, 2019

    Report

    Report Number
    3008642652-2019-03110
    Event Type
    Death
    Date Received
    May 3, 2019
    Date of Event
    April 6, 2019
    Report Date
    April 24, 2019
    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) AND ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. 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. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. DEVICE MANUFACTURE DATES: MONITOR: 09/20/2017. ELECTRODE BELT: 08/25/2011.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT WAS TREATED AND PASSED AWAY ON (B)(6) 2019. IT WAS REPORTED THAT THE PATIENT HAD BEEN WEARING THE LIFEVEST UNTIL BEING ADMITTED TO THE ICU. THE DEVICE WAS REMOVED IN THE ICU BECAUSE RESUSCITATION EFFORTS WERE BEING ATTEMPTED. IT WAS REPORTED THAT PRIOR TO BEING ADMITTED TO THE ICU, THE PATIENT WAS IN A DIFFERENT HOSPITAL FLOOR AND HAD BEEN CODING THAT MORNING AND HAD LOST CONSCIOUSNESS. THE NURSE DID NOT RECALL HEARING THE LIFEVEST ALARM OR GIVE COMMANDS. PER REVIEW OF THE EVENT, THE PATIENT WAS TREATED ONCE BY THE LIFEVEST PRIOR TO PASSING. THE DEVICE INITIALLY DETECTED AN ARRHYTHMIA AT 09:14:13 ON (B)(6) 2019 WHILE THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 65 BPM WITH PVCS AND CPR ARTIFACT. THE DEVICE EXITED THE DETECTION SEQUENCE AT 09:14:48. THERAPY ELECTRODE PLACEMENT FAULT FLAGS ARE SEEN FROM 09:26:35 TO 10:31:37. BETWEEN 10:56:34 AND 10:57:33, THE DEVICE DETECTED AN ARRHYTHMIA TWICE WHILE THE PATIENT WAS IN BRADYCARDIA AT 50 BPM WITH CPR ARTIFACT. THE DETECTION SEQUENCE WAS EXITED AT 10:57:36. AT 10:57:59 THE DEVICE DETECTED AN ARRHYTHMIA WHILE THE PATIENT WAS IN BRADYCARDIA AT 25 BPM WITH CPR ARTIFACT. GEL WAS RELEASED AT 10:58:24 AND AT 10:58:43, THE DEVICE DELIVERED A LOW ENERGY TREATMENT SHOCK WHILE THE PATIENT WAS IN BRADYCARDIA AT 25 BPM WITH CPR ARTIFACT. THE POST-SHOCK RHYTHM WAS BRADYCARDIA AT 50 BPM WITH PVCS. PER THE CONTINUOUS ECG RECORDINGS, FROM 10:58:43 UNTIL THE ELECTRODE BELT WAS DISCONNECTED AT 11:35:22 ON (B)(6) 2019, THE PATIENT WAS IN BRADYCARDIA FROM 40 BPM TO 50 BPM WITH CPR ARTIFACT. THE RHYTHM THEN TRANSITIONED TO SINUS TACHYCARDIA AT 110 BPM DEGRADING TO ASYSTOLE WITH MOTION ARTIFACT. CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. DURING THE DELIVERY OF THE SHOCK, AN IMPEDANCE OF 0 OHMS WAS OBSERVED AND THE ENERGY DELIVERED IN THE SHOCK WAS 5 JOULES. THE LOW ENERGY SHOCK WAS LIKELY DUE TO THE PULSE BEING DELIVERED INTO AN OPEN LOAD. THIS IS CONSISTENT WITH 0 OHM IMPEDANCE. THE CAUSE OF THE OPEN LOAD AND REPORTED IMPEDANCE WAS LIKELY DUE TO THE THERAPY PADS ON THE LIFEVEST NOT MAKING FULL CONTACT WITH THE PATIENT AT THE TIME OF THE DEFIBRILLATION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370524 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| O