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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problems Signal Artifact/Noise (1036); Misconnection (1399)

Patient Problems Bradycardia (1751); Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 01/10/2023

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 does not indicate any device 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 an appropriate treatment which converted the arrhythmia to a slower rhythm and a non-lifevest defibrillation.The device was started up at 08:46:17 on (b)(6) 2023.At 18:23:18 on (b)(6) 2023, an arrhythmia was detected.Ecg shows vf.At 18:23:55, the patient received the appropriate treatment.The rhythm at the time of treatment was vf.Post shock rhythm was sinus rhythm @ 40 bpm.At 18:36:20, an arrhythmia was detected.Ecg shows sinus tachycardia @ 110 bpm with motion/tactile artifact.The rhythm then transitions to sinus bradycardia @ 30 bpm with pvc¿s.The rhythm then degrades to vt @ 190 bpm with motion artifact and electrode lead all off.The rhythm then degrades to fine vf with varying amplitudes.Vt/vf was visible during the arrhythmia detected at 18:36:20.However, cpr/motion artifact, electrode lead fall off, and varying amplitudes prevented the lifevest from treating the patient.At 18:42:33, the patient received the non-lifevest defibrillation.The rhythm at time of treatment was vf.Post shock rhythm was obscured due to cpr/electrode lead fall off.The electrode belt was disconnected at 19:16:05 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: 16554933
• MDR Text Key: 311423714
• Report Number: 3008642652-2023-02586
• Device Sequence Number: 1
• Product Code: MVK
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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: 02/22/2023
• 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