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 Arrhythmia (1721); Bradycardia (1751); Asystole (4442)

Event Date 11/03/2022

Event Type  Death  

Manufacturer Narrative

The electrode belt and monitor have been returned and the evaluation is underway.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 four appropriate treatments, three of which converted the arrhythmias to a slower rhythm and one which resulted in post shock asystole.The device was started up at 07:31:46 on (b)(6) 2022.At 20:06:45, an arrhythmia was detected.Ecg shows sinus rhythm @ 80 bpm degrading to vf.At 20:07:21, the patient received the first appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was asystole with motion artifact for 26 seconds transitioning to sinus bradycardia @ 20 bpm.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.At 20:08:47, an arrhythmia was detected.Ecg shows vf.At 20:09:17, the patient received the second appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus bradycardia @ 30 bpm.At 20:09:53, an arrhythmia was detected.Ecg shows vf.At 20:10:29, the patient received the third appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus bradycardia @ 30 bpm.At 20:11:15, an arrhythmia was detected.Ecg shows vf.At 20:11:51, the patient received the fourth appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus bradycardia @ 40 bpm.The device was shut down at 1:08:57 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: 16059866
• MDR Text Key: 306245365
• Report Number: 3008642652-2022-26983
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• 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: 11/29/2022
• 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