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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problem Signal Artifact/Noise (1036)

Patient Problems Bradycardia (1751); Tachycardia (2095); Heart Block (4444)

Event Date 04/30/2022

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2022 while reportedly wearing the lifevest.  the device was started up at 00:45:30 on (b)(6) 2022.At 13:01:44, an arrhythmia was detected.Ecg shows sinus bradycardia @ 30 bpm with nsvt/ cpr/electrode lead fall off.The rhythm then grades to vt @ 200 bpm with cpr/tactile artifact/electrode lead fall off.The device properly detected vt from approximately 13:01:16 to 13:02:00.Cpr, tactile artifact, electrode lead fall off, and heart rate not in detection sequence long enough prevented the lifevest from treating the patient.At 13:02:01, the patient received a non-lifevest defibrillation.Rhythm at time of treatment was vt @ 200 bpm with cpr/tactile artifact/electrode lead fall off.Post shock rhythm was sinus bradycardia from 10-80 bpm with hb.The patient was in vt for approximately 45 seconds before receiving the defibrillation.The device was shut down at 13:46:31 on (b)(6) 2022.

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 been returned and the evaluation is underway.The device flag data from the last download does not indicate any device 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
• 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: 15277328
• MDR Text Key: 298416901
• Report Number: 3008642652-2022-22647
• 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: 08/23/2022

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: LIFEVEST WCD 4000 SYSTEM
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 08/23/2022
• 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