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 Atrial Fibrillation (1729); Bradycardia (1751); Idioventricular Rhythm (1923); Tachycardia (2095); Ventricular Fibrillation (2130); Asystole (4442); Heart Block (4444)

Event Date 05/03/2022

Event Type  Death  

Manufacturer Narrative

The electrode belt and monitor have 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) 2022 while reportedly wearing the lifevest.The patient received an appropriate treatment which converted the arrhythmia to a slower rhythm.The patient also received a non-lifevest defibrillation.  the device was started up at 09:03:37 on (b)(6) 2022.At 12:18:56, an arrhythmia was detected.Ecg shows af with rvr @ 150 bpm with motion artifact.The rhythm then degrades to vt @ 180 bpm.At 12:19:32, the patient received the appropriate treatment.Rhythm at time of treatment was vt @ 150 bpm with motion artifact.Post shock rhythm was sinus bradycardia from 30-10 bpm with motion artifact and hb.The rhythm then transitions to sinus bradycardia @ 40 bpm with hb.At 12:37:10, an arrhythmia was detected.Ecg shows idioventricular rhythm @ 50 bpm degrading to vf with varying amplitudes.The rhythm then degrades to asystole.The device properly detected vf.However, varying amplitude and asystole prevented the lifevest from treating the patient.From 12:58:48 to 13:12:44, an arrhythmia was detected four times.Ecg shows asystole with cpr/motion artifact/electrode lead fall off and cardiac activity.The rhythm then degrades to vf with cpr/motion artifact and electrode lead fall off.The device properly detected vf.However, cpr/motion artifact/electrode lead fall off prevented the lifevest from treating the patient.At 13:12:44, the patient received a non-lifevest defibrillation.Rhythm at time of treatment was vf with cpr/motion artifact and electrode lead fall off.Post shock rhythm was asystole with cpr/motion artifact and electrode lead fall off.The electrode belt was disconnected at 13:15:42 on (b)(6) 2022.The patient passed away on (b)(6) 2022.

• 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: 14831293
• MDR Text Key: 294788578
• Report Number: 3008642652-2022-20537
• 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: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• 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: 06/24/2022
• 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