LIFEVEST WCD 4000 SYSTEM

by ZOLL MANUFACTURING CORPORATION

Other DevicesFDA 510kOn market since 2015
25
High Risk

The LIFEVEST WCD 4000 SYSTEM by ZOLL MANUFACTURING CORPORATION has a safety score of 25 out of 100, placing it in the high-risk category. Based on FDA MAUDE data, there have been 138,165 adverse event reports including 3512 deaths since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #6229 out of 6230 devices in the Other Devices category.

Adverse Events

138,165

Total reports filed with FDA MAUDE

Death Reports

3512

Death reports associated with device

Incident Rate

0

Per 10,000 units in use

Recalls

0

No recalls on record

Estimated Units in Use

0

Based on market data estimates

Category Ranking

#6229 of 6230

In Other Devices by safety score

How This Compares

Safety Score25/100
Category Average
72
This Device
25
Best in Category
84

Important Context

Adverse event reports reflect reported incidents, not confirmed device failures. Higher numbers may indicate greater device usage, better reporting systems, or increased awareness. This data should be one factor in your research — always consult your physician.