BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 12870536 · Received November 24, 2021

    Report

    Report Number
    3008642652-2021-10359
    Event Type
    Death
    Date Received
    November 24, 2021
    Date of Event
    September 14, 2021
    Report Date
    November 23, 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

    THE ELECTRODE BELT HAS BEEN RETURNED AND THE EVALUATION IS UNDERWAY. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD (11/01/2021) DOES NOT INDICATE ANY DEVICE MALFUNCTION. THE REVIEW OF THE DATA INDICATED THAT THE DEVICE POWERED ON NORMALLY AND WAS ABLE TO ACQUIRE THE PATIENT'S ECG SIGNAL ON THE LAST DAY OF USE CAPTURED IN THE DATA DOWNLOAD. NO DEFICIENCIES ALLEGED. DEVICE EVALUATION OF THE MONITOR 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 ROOT CAUSE FOR THE OPEN RESISTOR COULD NOT BE POSITIVELY IDENTIFIED. DEVICE MANUFACTURE DATE: MONITOR 04/20/2021. BELT 09/26/2018.

    Description of Event or Problem · 0

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY IN THE HOSPITAL WHILE WEARING THE LIFEVEST ON (B)(6) 2021. REVIEW OF THE PATIENT'S DOWNLOAD DATA INDICATES THE PATIENT RECEIVED FIVE APPROPRIATE SHOCKS ON THE DATE OF PASSING. THE DEVICE WAS STARTED UP AT 22:35:40 ON (B)(6) 2021. THE PATIENT WAS IN SINUS RHYTHM AT 80 BPM WITH PVC'S AND BBB AT 01:52:59 ON (B)(6) 2021. THE PATIENT'S RHYTHM TRANSITIONED TO SVT AT 150 BPM WITH MOTION ARTIFACT BEFORE SELF-CONVERTING TO SINUS RHYTHM AT 80 TO 90 BPM WITH MOTION ARTIFACT, NSVT, AND BBB BY 02:26:36. THE PATIENT WAS IN SINUS RHYTHM AT 80 TO 90 BPM WITH PVC'S, NSVT, BBB, AND MOTION ARTIFACT AT 02:52:40. THE PATIENT'S RHYTHM TRANSITIONED TO SVT AT 180 BPM WITH MOTION ARTIFACT BEFORE SELF-CONVERTING TO SINUS TACHYCARDIA AT 100 BPM WITH PVC'S, NSVT, BBB, AND MOTION ARTIFACT BY 05:54:11. THE PATIENT'S RHYTHM TRANSITIONED TO VT AT 230 BPM WITH MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF AT 06:07:11. THE PATIENT RECEIVED THE FIRST APPROPRIATE SHOCK AT 06:08:56. THE PATIENT'S RHYTHM AT THE TIME OF THE SHOCK WAS VT AT 240 BPM WITH MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF. THE PATIENT'S POST-SHOCK RHYTHM WAS AF/SVT AT 180 BPM WITH PVC'S AND MOTION ARTIFACT/TACTILE ARTIFACT AND ELECTRODE LEAD FALL OFF. THE PATIENT RECEIVED THE SECOND APPROPRIATE SHOCK AT 06:09:37. THE PATIENT'S RHYTHM AT THE TIME OF THE SHOCK WAS VT AT 180 BPM WITH MOTION ARTIFACT/TACTILE ARTIFACT AND ELECTRODE LEAD FALL OFF. THE PATIENT'S POST-SHOCK RHYTHM WAS NSVT WITH MOTION ARTIFACT/TACTILE ARTIFACT AND ELECTRODE LEAD FALL OFF. THE PATIENT RECEIVED THE THIRD APPROPRIATE SHOCK AT 06:10:12. THE PATIENT'S RHYTHM AT THE TIME OF THE SHOCK WAS VT WITH MOTION ARTIFACT/TACTILE ARTIFACT AND ELECTRODE LEAD FALL OFF. THE PATIENT'S POST-SHOCK RHYTHM WAS NSVT WITH MOTION ARTIFACT/TACTILE ARTIFACT AND ELECTRODE LEAD FALL OFF. THE PATIENT RECEIVED THE FOURTH APPROPRIATE SHOCK AT 06:10:49. THE PATIENT'S RHYTHM AT THE TIME OF THE SHOCK WAS VT WITH MOTION ARTIFACT/TACTILE ARTIFACT AND ELECTRODE LEAD FALL OFF. THE PATIENT'S POST-SHOCK RHYTHM WAS NSVT WITH MOTION ARTIFACT/TACTILE ARTIFACT AND ELECTRODE LEAD FALL OFF. THE PATIENT RECEIVED THE FIFTH APPROPRIATE SHOCK AT 06:11:23. THE PATIENT'S RHYTHM AT THE TIME OF THE SHOCK WAS VT WITH MOTION ARTIFACT/TACTILE ARTIFACT AND ELECTRODE LEAD FALL OFF. THE PATIENT'S POST-SHOCK RHYTHM WAS NSVT WITH MOTION ARTIFACT/TACTILE ARTIFACT AND ELECTRODE LEAD FALL OFF. THE PATIENT'S RHYTHM THEN DEGRADED TO VT AT 270 BPM WITH MOTION ARTIFACT. THE PATIENT'S RHYTHM WAS OBSCURED BY CPR/MOTION ARTIFACT AT 06:12:51. THE PATIENT'S RHYTHM DEGRADED TO VF WITH CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF AT 06:14:15 UNTIL 06:17:41. THE LIFEVEST DETECTED THE VF ARRHYTHMIA, BUT CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF PREVENTED DELIVERY OF A SHOCK. THE PATIENT WAS IN ASYSTOLE WITH CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF FROM APPROXIMATELY 07:21:16 UNTIL THE ELECTRODE BELT DISCONNECTION AT 07:25:12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765566 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death