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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 07/17/2022

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a patient passed away while wearing the lifevest on (b)(6) 2022.Review of the download data, indicates the patient received two appropriate treatments during vf and one inappropriate treatment in response to oversensing of cardiac activity.At 03:55:27, the patient received the first appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was vt at 270 bpm with motion artifact.At 03:56:01, the patient received the second appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was asystole with intermittent cardiac activity.At 03:56:58, the patient received the inappropriate treatment during asystole in response to oversensing of cardiac activity.The patient's post-shock rhythm was sinus bradycardia at 30 bpm.From 04:13:12 to 04:19:05, the patient's rhythm was sinus bradycardia at 20 bpm with unconducted p waves degrading to an idioventricular rhythm at 10 bpm with low amplitude cardiac signal.Device was shutdown at 04:45:44.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.

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.

• 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: 15208829
• MDR Text Key: 297682540
• Report Number: 3008642652-2022-21986
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• 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: 08/05/2022
• 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