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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Device Sensing Problem (2917)

Patient Problems Bradycardia (1751); Idioventricular Rhythm (1923); Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 10/17/2021

Event Type  Death  

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 were present and performed resuscitation efforts, including externally defibrillating the patient.Per clinical review of the continuous ecg recording, the device was started up at 11:56:36 on (b)(6) 2021.The patient was in an idioventricular rhythm at 70 bpm at approximately 12:45:12.The patient's rhythm slowed to an idioventricular rhythm at 50 bpm with cpr/motion artifact and electrode lead fall off at approximately 12:46:50.The patient's rhythm then transitioned to sinus rhythm at 80 bpm with cpr/motion artifact and electrode lead fall off at approximately 12:49:38.At approximately 12:57:18 the patient's rhythm transitioned to an idioventricular rhythm/sinus bradycardia from 60 to 30 bpm with cpr/motion artifact and electrode lead fall off.The patient remained in an idioventricular rhythm at 90 bpm with pvc's until their rhythm degraded to vt at 170 bpm with cpr/motion artifact and electrode lead fall off at approximately 13:00:59.The patient received an external defibrillation at approximately 13:01:30.The patient's rhythm at the time of the external defibrillation was vt at 130 bpm.The patient's post-shock rhythm was obscured by cpr/motion artifact and electrode lead fall off.The patient received six additional external defibrillations at 13:03:11, 13:05:06, 13:07:09, 13:10:15, 13:13:24, and 13:16:31.The patient's rhythm at the time of each external defibrillation was vf with cpr/motion artifact and electrode lead fall off.The patient's post-shock rhythm for each of the external defibrillations was obscured by cpr/motion artifact and electrode lead fall off.The patient remained in vf with cpr/motion artifact and electrode lead fall off until cpr/motion artifact and electrode lead fall off obscured the patient's rhythm at 13:20:33.Svt at 160 bpm with cpr/motion artifact and electrode lead fall off was seen at 13:20:41.The patient received an eighth external defibrillation at 13:20:44.The patient's rhythm at the time of the external defibrillation was svt at 160 bpm with cpr/motion artifact and electrode lead fall off.The patient's post-shock rhythm was obscured by cpr/motion artifact and electrode lead fall off.The patient's rhythm degraded to vf with cpr/motion artifact and electrode lead fall off at approximately 13:24:24.The patient received a ninth external defibrillation at 13:25:00.The patient's rhythm at the time of the external defibrillation was vt at 200 bpm.The patient's post-shock rhythm was obscured by cpr/motion artifact and electrode lead fall off.Cpr/motion artifact, electrode lead fall off, and the external defibrillations prevented the lifevest from detecting the vt/vf arrhythmias throughout the event.The patient was in an idioventricular rhythm from 30 to 40 bpm with cpr/motion artifact and electrode lead fall off from approximately 13:29:20 until the electrode belt disconnection at 13:35:34.The device was started up again at 21:06:37 on (b)(6) 2021.The patient's rhythm was obscured by motion artifact and electrode lead fall off until the electrode belt was disconnected at 21:08:39.

Manufacturer Narrative

Device evaluation of the electrode belt has been completed.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 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 open r781 resistor is consistent with the patient receiving an external defibrillation while wearing the lifevest.Device manufacture date: monitor 09/09/2020, belt 11/21/2018.

• 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
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13009355
• MDR Text Key: 282263468
• Report Number: 3008642652-2021-10392
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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: 09/09/2020
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2020
• 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