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

Model Number WCD 4000

Device Problem Device Sensing Problem (2917)

Patient Problems Bradycardia (1751); Ventricular Fibrillation (2130); Asystole (4442)

Event Date 12/23/2021

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.Per clinical review of the continuous ecg recording, the device was started up at 18:19:26 on (b)(6) 2021.Asystole was detected at 00:27:25.Ecg shows idioventricular rhythm at 70 bpm degrading to vf with low amplitude cardiac signal, motion artifact, and electrode lead fall off.Device was shutdown at 00:29:51 on (b)(6) 2021.Per continuous holter recording, the patient's rhythm was sinus bradycardia at 40 bpm with hb.Rhythm transitions to an idioventricular rhythm from 90-80 bpm with pvc's, low amplitude cardiac signal, cpr motion artifact, and electrode lead fall off.Rhythm then degrades to vf with low amplitude cardiac signal, motion artifact, and electrode lead fall off.The rhythm then degrades to asystole with motion artifact and electrode lead fall off from approximately 23:58:47 until the device was shutdown at 00:29:51 on (b)(6) 2021.Motion artifact and electrode lead fall off prevented the lifevest from treating while the patient's rhythm was in vf.

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 1 hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5 hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5 hz 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.

• 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: steven kyle ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13549851
• MDR Text Key: 285755232
• Report Number: 3008642652-2022-01778
• 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: 02/17/2022

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: 01/21/2022
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2020
• 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