DREAMSTATION AUTO CPAP

by RESPIRONICS, INC.

Sleep & RespiratoryFDA 510kOn market since 2015
25
High Risk

The DREAMSTATION AUTO CPAP by RESPIRONICS, INC. has a safety score of 25 out of 100, placing it in the high-risk category. Based on FDA MAUDE data, there have been 128,380 adverse event reports including 1340 deaths since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #52 out of 52 devices in the Sleep & Respiratory category.

Adverse Events

128,380

Total reports filed with FDA MAUDE

Death Reports

1340

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

#52 of 52

In Sleep & Respiratory by safety score

How This Compares

Safety Score25/100
Category Average
69
This Device
25
Best in Category
83

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.