RESPIRONICS CALIFORNIA, INC

Manufacturer adverse-event records for RESPIRONICS CALIFORNIA, INC 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 · 2005–2021 · heavy-book · typical Death-code · injury-light

Injury-mix signature

RESPIRONICS CALIFORNIA, INC is lighter on Injury codes

Injury-coded event_type share is 0.8% (injury-light tercile) beside 0.24% Death-coded (typical). Volume band: heavy.

What the Injury-mix reading shows for RESPIRONICS CALIFORNIA, INC

The standout signal for RESPIRONICS CALIFORNIA, INC is Injury-mix: 0.8% Injury-coded (injury-light) beside 0.24% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair RESPIRONICS CALIFORNIA, INC with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 5 device types, led in this extract by Malfunction at 27,251 (99.0% of event_type total). Peak single-year volume reaches 10,957 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

27,525
Total Reports
65
Event-type Death
209
Injury Reports
5
Device Types

Event Types

Malfunction 27,251 (99.0%)
Injury 209 (0.8%)
Death 65 (0.2%)

Patient Outcomes

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

27,311 (99.3%)
Required Intervention 83 (0.3%)
Death 48 (0.2%)
Other 21 (0.1%)
Life Threatening 19 (0.1%)
R 7 (0.0%)
Hospitalization 5 (0.0%)
O 2 (0.0%)
Congenital Anomaly 2 (0.0%)
D 1 (0.0%)
L 1 (0.0%)
S 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

05
2005: 1
07
2007: 1
08
2008: 2
14
2014: 4
15
2015: 2,044
16
2016: 3,634
17
2017: 3,922
18
2018: 3,042
19
2019: 10,957
20
2020: 3,582
21
2021: 336