BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11830160 · Received May 16, 2021

    Report

    Report Number
    3008642652-2021-04139
    Event Type
    Death
    Date Received
    May 16, 2021
    Date of Event
    March 22, 2021
    Report Date
    May 13, 2021
    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. 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 EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE CABLE CONNECTING ECG "C" AND ECG "D" WAS PULLED FROM THE STRAIN RELIEF, DAMAGING WIRES IN THE CABLE. THE ROOT CAUSE FOR THE STRAINED CABLE WAS EXCESSIVE FORCE. DEVICE MANUFACTURE DATE: MONITOR 07/06/2015, BELT 08/12/2015.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY IN THE HOSPITAL WHILE WEARING THE LIFEVEST ON (B)(6) 2021. IT WAS REPORTED THAT HOSPITAL STAFF PERFORMED CPR ON THE PATIENT AND DAMAGED THE LIFEVEST DURING CPR. REVIEW OF THE DOWNLOAD DATA, INDICATES THE PATIENT RECEIVED TWO APPROPRIATE TREATMENTS DURING VF AND 4 INAPPROPRIATE TREATMENTS IN RESPONSE TO CPR/MOTION ARTIFACT. PER CLINICAL REVIEW OF THE CONTINUOUS ECG INFORMATION, THE DEVICE WAS STARTED UP AT 13:44:18 ON (B)(6) 2021. THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 60 BPM AT 04:17:20. THE PATIENT'S RHYTHM DEGRADED TO VF AT 04:17:49. THE PATIENT RECEIVED THE FIRST APPROPRIATE TREATMENT AT 04:18:27. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS VF. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. THE PATIENT'S RHYTHM DEGRADED TO VF AT APPROXIMATELY 04:18:25. THE DEVICE WAS SHUTDOWN WHILE THE PATIENT WAS IN VF AT 04:18:45. THE DEVICE WAS STARTED UP AGAIN AT 04:19:36. THE PATIENT WAS IN VF AT THE TIME OF THE DEVICE STARTUP. THE LIFEVEST PROPERLY DETECTED THE VF ARRHYTHMIA, BUT RESPONSE BUTTON USE DURING THE DETECTION SEQUENCE PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT UNTIL 04:27:05. IT WAS NOT REPORTED WHO WAS PRESSING THE RESPONSE BUTTONS. THE PATIENT RECEIVED THE SECOND APPROPRIATE TREATMENT AT 04:27:05. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS VF WITH CPR/MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. THE PATIENT WAS IN ASYSTOLE, WHICH TRANSITIONED TO AN IDIOVENTRICULAR RHYTHM AT 40 BPM FROM 04:27:31 TO 04:28:09. THE PATIENT RECEIVED THE FIRST INAPPROPRIATE TREATMENT AT 04:29:34. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS AN IDIOVENTRICULAR RHYTHM AT 40 BPM WITH CPR/MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. THE PATIENT RECEIVED THE SECOND INAPPROPRIATE TREATMENT AT 04:30:08. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS ASYSTOLE WITH CPR/MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE. THE PATIENT RECEIVED THE THIRD INAPPROPRIATE TREATMENT AT 04:30:36. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT AND POST-SHOCK RHYTHM WERE OBSCURED BY CPR/MOTION ARTIFACT. THE PATIENT RECEIVED THE FOURTH INAPPROPRIATE TREATMENT AT 04:31:08. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS OBSCURED BY CPR/MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. THE PATIENT WAS IN ASYSTOLE WITH CPR/MOTION ARTIFACT AT 04:54:16. THE PATIENT'S RHYTHM WAS OBSCURED BY CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF AT THE TIME OF THE ELECTRODE BELT DISCONNECTION AT 04:55:13 ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726529 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death