RESPIRONICS CALIFORNIA, LLC

Manufacturer adverse-event records for RESPIRONICS CALIFORNIA, LLC come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2014–2025 · thin-book · typical Death-code · injury-light

Volume signature

RESPIRONICS CALIFORNIA, LLC is a thinner MAUDE footprint

RESPIRONICS CALIFORNIA, LLC accounts for 5,061 FDA MAUDE reports (#371 of 434, thin-book tercile). Death-coded event_type share is 0.34% (typical); Injury share 1.5% (injury-light).

What the volume reading shows for RESPIRONICS CALIFORNIA, LLC

The standout signal for RESPIRONICS CALIFORNIA, LLC is filing volume: 5,061 adverse-event reports in FDA MAUDE (#371 of 434, thin-book). Death-coded event_type share sits at 0.34% (typical).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 3 device types, led in this extract by Malfunction at 4,966 (98.1% of event_type total). Peak single-year volume reaches 3,195 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,061
Total Reports
17
Event-type Death
78
Injury Reports
3
Device Types

Event Types

Malfunction 4,966 (98.1%)
Injury 78 (1.5%)
Death 17 (0.3%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

4,944 (97.7%)
Required Intervention 78 (1.5%)
Death 21 (0.4%)
Other 8 (0.2%)
Life Threatening 6 (0.1%)
D 2 (0.0%)
R 1 (0.0%)

Yearly Trend

14
2014: 2
15
2015: 7
16
2016: 2
17
2017: 7
18
2018: 2
19
2019: 1
20
2020: 3
21
2021: 1,713
22
2022: 3,195
23
2023: 127
24
2024: 1
25
2025: 1