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 12/04/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of the monitor and electrode belt 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.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2021 while wearing the lifevest.It was reported that the patient was at home at the time of passing.Review of the patient's download data revealed that prior to passing, the patient received two appropriate treatments from the lifevest.At 17:17:07, the patient received the first treatment.The patient's rhythm at the time of the treatment was vt at 220 bpm.The post-shock rhythm was sinus tachycardia at 100 bpm with motion artifact transitioning to vt at 170 bpm with motion artifact.At 17:17:40, the patient received the second treatment.The patient's rhythm at the time of the treatment was vt at 190 bpm with motion artifact.The post shock rhythm was asystole for 1 minute and 59 seconds transitioning to sinus bradycardia at 25 bpm.The rhythm then transitions to vt at 110 bpm.The rhythm then slows to an idioventricular rhythm at 90 bpm.The patient reportedly passed away shortly after the treatments were delivered while in the hospital.

• 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: mary ward ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13255520
• MDR Text Key: 283808287
• Report Number: 3008642652-2022-00528
• 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: 01/13/2022

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: 12/20/2021
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• 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; Other