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 10/01/2023

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 and five inappropriate treatments.The device was started up at 04:43:25 on (b)(6) 2023.At 06:12:46, an arrhythmia was detected.Ecg shows sinus bradycardia @ 30 bpm degrading to asystole with intermittent cardiac activity and cpr/motion artifact.At 06:13:58, the patient received the first inappropriate treatment.Oversensing of cardiac activity and cpr/motion artifact contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with intermittent cardiac activity and cpr/motion artifact.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with intermittent cardiac activity and cpr/motion artifact.At 06:14:20, the patient received the second inappropriate treatment.Oversensing of cardiac activity and cpr/motion artifact contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with intermittent cardiac activity and cpr/motion artifact.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with intermittent cardiac activity and cpr/motion artifact.At 06:15:55, the patient received the third inappropriate treatment.Oversensing of cardiac activity and cpr/motion artifact contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with intermittent cardiac activity and cpr/motion artifact.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with intermittent cardiac activity and cpr/motion artifact.At 06:16:26, the patient received the fourth inappropriate treatment.Oversensing of cardiac activity and cpr/motion artifact contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with intermittent cardiac activity and cpr/motion artifact.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with intermittent cardiac activity and cpr/motion artifact.At 06:20:35, an arrhythmia was detected.Ecg shows asystole with intermittent cardiac activity and cpr/motion artifact.At 06:21:42, the patient received the fifth inappropriate treatment.Oversensing of cardiac activity and cpr/motion artifact contributed to the false detection.The patient was in a non life-sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with intermittent cardiac activity and cpr/motion artifact.Post shock rhythm continued to be in asystole, which is a non life-sustaining rhythm, with intermittent cardiac activity and cpr/motion artifact.At 06:25:07, an arrhythmia was detected.Ecg shows asystole with intermittent cardiac activity and cpr/motion artifact transitioning to vf with cpr/motion/tactile artifact and electrode lead falloff.At 06:26:40, the patient received the appropriate treatment.Rhythm at the time of treatment was vf.Post shock rhythm was asystole with intermittent cardiac activity and cpr/motion artifact.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The electrode belt was disconnected at 06:29:16 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: 18771031
• MDR Text Key: 336137551
• Report Number: 3008642652-2024-02097
• 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