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); Ventricular Fibrillation (2130); Asystole (4442)

Event Date 10/05/2021

Event Type  Death  

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 08/15/2016.Belt 07/09/2018.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2021.Review of the patient's download data indicates the patient received four appropriate shocks on the date of passing.The device was started up at 06:16:57 on (b)(6) 2021.The patient was in sinus bradycardia at 50 bpm at 05:41:31.The patient's rhythm then degraded to vf.The patient received the first appropriate shock at 05:42:07 on (b)(6) 2021.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was sinus bradycardia at 40 bpm.The patient received the second appropriate shock at 05:59:41.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was sinus bradycardia at 40 bpm with pvc's.The patient's rhythm degraded to vf at 06:09:39.The response were pressed from 06:0+:59 to 06:11:58, delaying delivery of a shock.It was not reported who pressed the response buttons.The patient received the third appropriate shock at 06:12:43.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was asystole for 15 seconds, transitioning to an idioventricular rhythm at 30 bpm.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient's rhythm degraded to vf at 06:27:35.The patient received the fourth appropriate shock at 06:28:07.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was an idioventricular rhythm at 30 bpm, transitioning to vf.The patient was in an idioventricular rhythm at 30 bpm at 06:28:45 before their rhythm degraded to vf.The patient was in vf with cpr/motion artifact and response button use at 06:29:14.It was not reported who was pressing the response buttons.The patient was in vf with cpr/motion artifact at the time of the electrode belt disconnection.It was not reported who disconnected the electrode belt.

• 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: 12976292
• MDR Text Key: 282050790
• Report Number: 3008642652-2021-10364
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• 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: 10/26/2021
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• 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