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

Model Number WCD 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Tachycardia (2095); Asystole (4442)

Event Date 10/08/2021

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a patient passed away while wearing the lifevest on (b)(6) 2021.It was reported that ems removed the lifevest and performed resuscitation efforts.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 09:49:42 on (b)(6) 2021.The patient was in sinus tachycardia with bigeminy, nsvt, and motion artifact at 16:56:40.The patient's rhythm then transitioned to vt at 240 bpm.The lifevest detected the vt arrhythmia, but the response buttons were pressed, preventing delivery of a shock.It was not reported who was pressing the response buttons.The patient's rhythm then self-converted to af at 170 bpm with nsvt.The patient's rhythm then degraded to vf with motion artifact by 16:58:18.The patient received the first appropriate shock at 17:00:51.The patient's rhythm at the time of the treatment was vf with motion artifact.The patient's post-shock rhythm was asystole with intermittent cardiac activity, transitioning to vt at 260 bpm.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the second appropriate shock at 17:01:25.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was af at 130 bpm with pvc's and a pause before degrading to vf.The patient received the third appropriate shock at 17:01:59.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was af with rvr from 110 to 220 bpm, degrading to vf.The patient received the fourth appropriate shock at 17:02:31.The patient's rhythm at the time of the treatment was vf.The patient's post-shock rhythm was bradycardia at 20 bpm with hb, degrading to vt at 210 bpm before degrading to vf.The patient received the fifth appropriate shock at 17:03:03.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was sinus rhythm at 80 bpm, transitioning to af with rvr at 220 bpm with motion artifact.The patient's rhythm then degraded to vf with varying amplitudes, cpr/motion artifact, and electrode lead fall off.The patient was in vf with varying amplitudes, motion artifact, cpr/motion artifact, and electrode lead fall off between 17:03:29 and 17:08:26.Varying amplitudes, motion artifact, cpr/motion artifact, and electrode lead fall off prevented the lifevest from delivering a shock.Cpr/motion artifact and electrode lead fall off obscured the patient's rhythm from 17:08:27 until ems disconnected the electrode belt at 17:37:21.

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 08/27/2015; belt 09/19/2016.

• 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: 12793712
• MDR Text Key: 280675686
• Report Number: 3008642652-2021-09852
• 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: 11/09/2021

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: 10/14/2021
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• 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): Congenital Anomaly; Death