BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11083523 · Received December 28, 2020

    Report

    Report Number
    3008642652-2020-11509
    Event Type
    Death
    Date Received
    December 28, 2020
    Date of Event
    November 25, 2020
    Report Date
    January 7, 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 · 0

    H.3. DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B)(6) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DEATH) WAS CONFIRMED. THE ELECTRODE BELT ECG ACQUISITION AND PULSE DELIVERY CIRCUITRY WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. DEVICE EVALUATION OF MONITOR (B)(6) HAS BEEN COMPLETED. UPON INVESTIGATION THE MONITOR WAS NOT PROPERLY PRODUCING A DRIVEN GROUND SIGNAL. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN R781 DRIVEN GROUND RESISTOR ON THE COMPUTER/ANALOG BOARD. THE OPEN RESISTOR IS CONSISTENT WITH THE REPORTED EXTERNAL DEFIBRILLATION THAT WAS DELIVERED TO THE PATIENT WHILE WEARING THE LIFEVEST. THE LIFEVEST IS NOT DEFIBRILLATOR PROOF. THE ROOT CAUSE FOR THE OPEN RESISTOR WAS THE EXTERNAL DEFIBRILLATION DELIVERED TO THE PATIENT WHILE WEARING THE LIFEVEST. MANUFACTURE DATES: MONITOR 7/17/20149, ELECTRODE BELT 9/30/2015.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT (B)(6) 2021: PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021, THE PATIENT RECEIVED THREE NON-LIFEVEST DEFIBRILLATIONS AFTER THE SECOND LIFEVEST DEFIBRILLATION WAS DELIVERED. THE FIRST NON-LIFEVEST DEFIBRILLATION WAS RECEIVED AT 22:31:34, THE PATIENT'S RHYTHM AT TIME OF TREATMENT WAS ASYSTOLE WITH CPR AND MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE WITH CPR AND MOTION ARTIFACT. THE PATIENT'S RHYTHM THEN DEGRADED TO VT AT 200 BPM WITH CPR AND MOTION ARTIFACT. CPR AND MOTION ARTIFACT PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT DURING THIS TIME. THE LIFEVEST DECLARED A NON-TREATABLE RHYTHM AT 22:32:54. FROM 22:35:53 TO 23:08:18, THE PATIENT'S RHYTHM WAS ASYSTOLE WITH CPR AND MOTION ARTIFACT. THE PATIENT'S RHYTHM THEN TRANSITIONED TO AN IDIOVENTRICULAR RHYTHM AT 40 BPM WITH CPR AND MOTION ARTIFACT. THE PATIENT RECEIVED THE SECOND NON-LIFEVEST DEFIBRILLATION. THE PATIENT'S RHYTHM AT TIME OF TREATMENT WAS VT AT 200 BPM WITH CPR AND MOTION ARTIFACT. THE PATIENT'S POST SHOCK RHYTHM WAS OBSCURED BY CPR AND MOTION ARTIFACT. THE PATIENT WAS IN VT FOR APPROXIMATELY 3.5 MINUTES BEFORE RECEIVING THE DEFIBRILLATION. THE RHYTHM TRANSITIONED TO VT AT 150 BPM WITH CPR AND MOTION ARTIFACT. THE PATIENT RECEIVED A THIRD NON-LIFEVEST DEFIBRILLATION. THE PATIENT'S RHYTHM AT TIME OF TREATMENT WAS VT AT 120 BPM. THE PATIENT'S POST SHOCK RHYTHM WAS AN IDIOVENTRICULAR RHYTHM AT 70 BPM WITH CPR AND MOTION ARTIFACT. THE PATIENT WAS IN VT FOR 2.5 MINUTES BEFORE RECEIVING THE NON-LIFEVEST DEFIBRILLATION. THE RHYTHM THEN TRANSITIONED TO VT FROM 100 BPM TO 190 BPM WITH VARYING HR, VARYING AMPLITUDES, AND MOTION ARTIFACT. THE RHYTHM THEN SLOWS TO AN IDIOVENTRICULAR RHYTHM AT 90 BPM, THEN SLOWING TO AN IDIOVENTRICULAR RHYTHM AT 70 BPM FROM APPROXIMATELY 22:35:53 UNTIL THE DEVICE SHUTDOWN 23:08:18 ON (B)(6) 2020. THE CPR AND MOTION ARTIFACT, HEART RATE BELOW THE PATIENT'S PHYSICIAN PRESCRIBED TREATMENT THRESHOLD, VARYING HEART RATE AND VARYING AMPLITUDES PREVENTED THE LIFEVEST FROM TREATING THE PATIENT. AT 00:43:07 ON (B)(6) 2020, THE LIFEVEST WAS STARTED UP AGAIN. PER REVIEW OF THE PATIENT'S CONTINUOUS ECG RECORDINGS, FROM 00:43:07 TO 00:48:50, THE PATIENT'S RHYTHM WAS ASYSTOLE FROM 00:43:07 UNTIL THE ELECTRODE BELT WAS DISCONNECTED AT 00:48:50. A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2020 WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT THE PATIENT WAS FOUND UNCONSCIOUS AND RECEIVED AN EXTERNAL DEFIBRILLATION BY EMS WHILE WEARING THE LIFEVEST PRIOR TO PASSING. REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALS THAT PRIOR TO PASSING, THE PATIENT RECEIVED ONE APPROPRIATE TREATMENT, AND ONE INAPPROPRIATE TREATMENT FROM THE LIFEVEST. AT 21:46:23, THE PATIENT RECEIVED AN APPROPRIATE TREATMENT FROM THE LIFEVEST. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS VENTRICULAR TACHYCARDIA (VT) AT 140 BPM AND THE POST-SHOCK RHYTHM WAS ATRIAL FIBRILLATION (AF) AT 60 BPM. AT 22:23:35, THE PATIENT RECEIVED THE INAPPROPRIATE TREATMENT FROM THE LIFEVEST. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS ASYSTOLE, A NON-LIFE-SUSTAINING RHYTHM, WITH CPR AND MOTION ARTIFACT AND THE POST-SHOCK RHYTHM WAS ASYSTOLE WITH CARDIAC ACTIVITY AND MOTION ARTIFACT. CPR AND MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. IT WAS REPORTED BY THE PATIENT'S NURSE THAT THE PATIENT PASSED AWAY AROUND 23:02 ON (B)(6) 2020, WHILE IN ASYSTOLE. THERE IS NO INDICATION THAT THE INAPPROPRIATE TREATMENT CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING AS THE PATIENT WAS IN A NON-LIFE-SUSTAINING RHYTHM PRIOR TO THE INAPPROPRIATE TREATMENT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DEATH) WAS CONFIRMED. THE ELECTRODE BELT ECG ACQUISITION AND PULSE DELIVERY CIRCUITRY WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE MONITOR WAS NOT PROPERLY PRODUCING A DRIVEN GROUND SIGNAL. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN R781 DRIVEN GROUND RESISTOR ON THE COMPUTER/ANALOG BOARD. THE OPEN RESISTOR IS CONSISTENT WITH THE REPORTED EXTERNAL DEFIBRILLATION THAT WAS DELIVERED TO THE PATIENT WHILE WEARING THE LIFEVEST. THE LIFEVEST IS NOT DEFIBRILLATOR PROOF. THE ROOT CAUSE FOR THE OPEN RESISTOR WAS THE EXTERNAL DEFIBRILLATION DELIVERED TO THE PATIENT WHILE WEARING THE LIFEVEST. MANUFACTURE DATES: MONITOR 7/17/20149, ELECTRODE BELT 9/30/2015.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON 11/25/2020 WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT THE PATIENT WAS FOUND UNCONSCIOUS AND RECEIVED AN EXTERNAL DEFIBRILLATION BY EMS WHILE WEARING THE LIFEVEST PRIOR TO PASSING. REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALS THAT PRIOR TO PASSING, THE PATIENT RECEIVED ONE APPROPRIATE TREATMENT, AND ONE INAPPROPRIATE TREATMENT FROM THE LIFEVEST. AT 21:46:23, THE PATIENT RECEIVED AN APPROPRIATE TREATMENT FROM THE LIFEVEST. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS VENTRICULAR TACHYCARDIA (VT) AT 140 BPM AND THE POST-SHOCK RHYTHM WAS ATRIAL FIBRILLATION (AF) AT 60 BPM. AT 22:23:35, THE PATIENT RECEIVED THE INAPPROPRIATE TREATMENT FROM THE LIFEVEST. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS ASYSTOLE, A NON-LIFE-SUSTAINING RHYTHM, WITH CPR AND MOTION ARTIFACT AND THE POST-SHOCK RHYTHM WAS ASYSTOLE WITH CARDIAC ACTIVITY AND MOTION ARTIFACT. CPR AND MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. IT WAS REPORTED BY THE PATIENT'S NURSE THAT THE PATIENT PASSED AWAY AROUND 23:02 ON (B)(6) 2020, WHILE IN ASYSTOLE. THERE IS NO INDICATION THAT THE INAPPROPRIATE TREATMENT CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING AS THE PATIENT WAS IN A NON-LIFE-SUSTAINING RHYTHM PRIOR TO THE INAPPROPRIATE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545509 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O