MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Electrical /Electronic Property Problem (1198)

Patient Problems Bradycardia (1751); Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 08/12/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of the monitor 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 the electrode belt has been completed.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.The root cause for the strained cable was excessive force.Device manufacture date: monitor 04/19/2019.Belt 08/26/2016.

Event Description

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 removed the battery of the lifevest.Per clinical review of the continuous ecg recording, the device was started up at 21:11:34 on (b)(6) 2021.The patient was in sinus rhythm from 80 to 90 bpm with pvc's at 21:14:16.The patient was in sinus tachycardia at 100 bpm with motion artifact at 22:47:51.The patient was in sinus bradycardia at 50 bpm with cpr/motion artifact and electrode lead fall off at approximately 09:02:00 on (b)(6) 2021.The patient's rhythm degraded to vf with cpr/motion artifact and electrode lead fall off at approximately 09:08:03.Cpr/motion artifact and electrode lead fall off intermittently obscured the patient's rhythm.Cpr/motion artifact and electrode lead fall off prevented the lifevest from detecting the vf arrhythmia.The patient received an external defibrillation at 09:20:49.The patient's rhythm at the time of the external defibrillation was vf with electrode lead fall off.The patient's post-shock rhythm was vf with cpr/motion artifact and electrode lead fall off.The patient remained in vf with cpr/motion artifact and electrode lead fall off until the device shutdown at 09:40:52 on (b)(6) 2021.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• MDR Report Key: 12753818
• MDR Text Key: 280259376
• Report Number: 3008642652-2021-09577
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• Combination Product (y/n): N
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death