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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bradycardia (1751); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 11/05/2021

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.The electrode belt has not been recovered.The device flag data from the last download ((b)(6) 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 manufacture date: monitor 06/27/2016; belt 03/10/2021.

Event Description

A us distributor contacted zoll to report that a patient passed away in the hospital on (b)(6) 2021.It was reported that hospital staff performed resuscitation efforts.Review of the patient's download data indicates the patient received two inappropriate shocks in response to oversensing of low amplitude cardiac signal and cpr/motion artifact on the date of passing.The device was started up at 18:40:13 on (b)(6) 2021.The patient was in sinus bradycardia at 50 bpm at 01:33:17 on (b)(6) 2021.The patient's rhythm then degraded to asystole with cpr/motion artifact.The patient received the first inappropriate shock at 01:37:55.The patient's rhythm at the time of the shock and post-shock rhythm were asystole with cpr/motion artifact.The patient received the second inappropriate shock at 01:38:31.The patient's rhythm at the time of the shock was asystole with cpr/motion artifact.The patient's post-shock rhythm was asystole with cpr/motion artifact and electrode lead fall off.The electrode belt was disconnected at 01:54:21.

• 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: 13196794
• MDR Text Key: 283470653
• Report Number: 3008642652-2022-00369
• 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: 01/07/2022

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: 12/13/2021
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2014
• 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