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

Model Number WCD 4000

Device Problem Signal Artifact/Noise (1036)

Patient Problems Bradycardia (1751); Idioventricular Rhythm (1923); Tachycardia (2095); Asystole (4442)

Event Date 08/29/2021

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 performed resuscitation efforts.Per clinical review of the continuous ecg recording, the device was started up at 21:14:42 on (b)(6) 2021.The patient was in a paced rhythm/sinus rhythm from 50 to 60 bpm with pvc's at 16:47:43.The patient's rhythm transitioned to an idioventricular rhythm at 70 bpm with cpr/motion artifact at approximately 16:51:56.The patient's rhythm then transitioned to vt at 110 bpm with cpr/motion artifact at 16:54:04.Cpr/motion artifact and the rate of the vt being below the physician-prescribed rate threshold of 150 bpm prevented the lifevest from delivering a shock.The patient received an external defibrillation at 16:57:02.The patient's rhythm at the time of the treatment was vt at 110 bpm with cpr/motion artifact.The patient's post-shock rhythm was obscured by cpr/motion artifact.The patient's rhythm transitioned to vt at 160 bpm with cpr/motion artifact at approximately 16:58:07 before degrading to asystole at 16:58:17.The cpr/motion artifact and the patient's rhythm degrading to asystole prevented the lifevest from detecting the vt arrhythmia.The patient's rhythm transitioned to bradycardia at 20 bpm with bigeminy and cpr/motion artifact at approximately 16:58:22.The patient's rhythm then transitioned to sinus tachycardia at 110 bpm with pvc's, cpr artifact, and electrode lead fall off at approximately 17:08:43.The patient's rhythm degraded to vt at 120 bpm with varying amplitudes, cpr/motion artifact, and electrode lead fall off at approximately 17:08:57.The patient remained in vt at 120 bpm with varying amplitudes, cpr/motion artifact, and electrode lead fall off until the electrode belt disconnection at 17:09:03.Cpr/motion artifact, the rate of the vt being less than the physician-prescribed rate threshold, and the electrode belt disconnection prevented the lifevest from detecting the vt arrhythmia.

Manufacturer Narrative

Device evaluation of the monitor and electrode belt has been completed.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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 manufacture date: monitor 12/28/2020; belt 07/24/2018.

• 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: 12897107
• MDR Text Key: 281494423
• Report Number: 3008642652-2021-10533
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/09/2021
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2020
• 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