V60 VENTILATOR
by RESPIRONICS CALIFORNIA, INC
The V60 VENTILATOR by RESPIRONICS CALIFORNIA, INC has a safety score of 41 out of 100, placing it in the elevated-risk category. Based on FDA MAUDE data, there have been 24,915 adverse event reports including 72 deaths since its introduction in 2015. With an estimated 0 units in use, the incident rate is 0 per 10,000 units. It ranks #49 out of 52 devices in the Sleep & Respiratory category.
Should you be concerned? A safety score of 41/100 warrants careful consideration. With 24,915 adverse event reports and 72 associated deaths, the risk profile is elevated compared to alternatives in the sleep & respiratory category (which averages 69/100). Ask your doctor about alternative devices with better safety records.
No recalls have been issued for this device — a positive indicator of manufacturing quality and design safety. On the market since 2015, this device has 11 years of real-world data — enough for long-term safety patterns to emerge.
Questions to Ask Your Doctor About the V60 VENTILATOR
1. “What alternatives exist to the V60 VENTILATOR?”This device ranks #49 of 52 in the Sleep & Respiratory category. There are 48 devices with better safety scores — ask if any are appropriate for your case.
2. “How many of these have you personally implanted or used?”Surgeon experience with a specific device significantly impacts outcomes. Higher procedure volume correlates with fewer complications.
3. “What are the specific risks for my case?”Overall adverse event rates (0 per 10,000) are averages — your individual risk depends on age, health conditions, and anatomy.
4. “Is there a newer generation of this device available?”The V60 VENTILATOR has been on the market since 2015 (11 years). Newer versions may have improved safety profiles based on lessons from earlier models.
Adverse Events
Total reports filed with FDA MAUDE
Death Reports
Death reports associated with device
Incident Rate
Per 10,000 units in use
Recalls
No recalls on record
Estimated Units in Use
Based on market data estimates
Category Ranking
In Sleep & Respiratory by safety score
How This Compares
Other Sleep & Respiratory Devices
7200E MICROPROCESSOR VENTILATOR
Unknown
ACHIEVA VENTILATOR
Unknown
ACHIEVA VOLUME VENTILATOR
Unknown
ADULT STAR VENTILATOR
Unknown
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.