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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problem Over-Sensing (1438)

Patient Problem Arrhythmia (1721)

Event Date 12/25/2023

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.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2023 while reportedly wearing the lifevest.The patient received four inappropriate treatments.The device was started up at 12:56:05 on (b)(6) 2023.At 13:20:46, an arrhythmia was detected.Ecg shows idioventricular rhythm @ 80 bpm with cpr/motion artifact.At 13:21:55, the patient received the first inappropriate treatment.Cpr/motion artifact contributed to the false detection.The rhythm at the time of treatment was idioventricular rhythm @ 80 bpm with cpr/motion artifact.Post shock rhythm was idioventricular rhythm @ 80 bpm with cpr/motion artifact.At 13:22:27, the patient received the second inappropriate treatment.Cpr/motion artifact contributed to the false detection.The rhythm at the time of treatment was idioventricular rhythm @ 70 bpm with cpr/motion artifact.Post shock rhythm was idioventricular rhythm @ 80 bpm with cpr/motion artifact.At 13:22:58, the patient received the third inappropriate treatment.Cpr/motion artifact contributed to the false detection.The rhythm at the time of treatment was idioventricular rhythm @ 80 bpm with cpr/motion artifact.Post shock rhythm was idioventricular rhythm @ 80 bpm with cpr/motion artifact.At 13:23:42, the patient received the fourth inappropriate treatment.Cpr/motion artifact contributed to the false detection.The rhythm at the time of treatment was obscured due to cpr/motion artifact.Post shock rhythm recorded cpr/motion artifact transitioning to vt @ 140 bpm.The device was shut down at 13:27:18 on (b)(6) 2023.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA
• Manufacturer Contact: zoll mfg corporation ; 121 gamma drive; pittsburgh, PA 15238
• MDR Report Key: 18771099
• MDR Text Key: 336138034
• Report Number: 3008642652-2024-02098
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIFEVEST WCD 4000 SYSTEM
• Date Manufacturer Received: 01/30/2024
• 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