RESPIRONICS, INC.

Manufacturer adverse-event records for RESPIRONICS, 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 · 1994–2026 · heavy-book · elevated Death-code · balanced

Volume signature

RESPIRONICS, INC. sits in the heavy MAUDE book

RESPIRONICS, INC. accounts for 328,914 FDA MAUDE reports (#10 of 434, heavy-book tercile). Death-coded event_type share is 1.58% (elevated); Injury share 15.7% (balanced).

What the volume reading shows for RESPIRONICS, INC.

The standout signal for RESPIRONICS, INC. is filing volume: 328,914 adverse-event reports in FDA MAUDE (#10 of 434, heavy-book). Death-coded event_type share sits at 1.58% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair RESPIRONICS, 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 20 device types, led in this extract by Malfunction at 272,124 (82.7% of event_type total). Peak single-year volume reaches 81,832 reports across 33 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

328,914
Total Reports
5,207
Event-type Death
51,496
Injury Reports
20
Device Types

Event Types

Malfunction 272,124 (82.7%)
Injury 51,496 (15.7%)
Death 5,207 (1.6%)
Other 65 (0.0%)
22 (0.0%)

Patient Outcomes

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

266,989 (81.3%)
Other 49,076 (14.9%)
Death 5,107 (1.6%)
Life Threatening 2,049 (0.6%)
Required Intervention 1,933 (0.6%)
Hospitalization 1,050 (0.3%)
O 644 (0.2%)
R 454 (0.1%)
Disability 277 (0.1%)
H 243 (0.1%)
D 174 (0.1%)
L 154 (0.0%)
S 132 (0.0%)
Congenital Anomaly 74 (0.0%)
C 60 (0.0%)

Yearly Trend

94
1994: 2
95
1995: 2
96
1996: 2
97
1997: 27
98
1998: 10
99
1999: 12
00
2000: 59
01
2001: 62
02
2002: 25
03
2003: 56
04
2004: 74
05
2005: 70
06
2006: 89
07
2007: 29
08
2008: 16
09
2009: 31
10
2010: 58
11
2011: 106
12
2012: 1,113
13
2013: 924
14
2014: 719
15
2015: 1,907
16
2016: 1,661
17
2017: 922
18
2018: 799
19
2019: 933
20
2020: 666
21
2021: 3,968
22
2022: 68,230
23
2023: 38,159
24
2024: 81,832
25
2025: 72,692
26
2026: 53,659