2026 data FDA MAUDE openFDA FDA Class II

Nebulizer (Direct Patient Interface)

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §868.5630 (Anesthesiology panel).

FDA MAUDE casebook

openFDA event book Nebulizer LIGHT-BOOK · MAUDE

#422 of 1000 · 2,847 reports · 1992–2026

  • BOOK 2,847 reports
  • RANK #422 of 1000
  • DEATH 43 death-typed
  • INJ 257 injury-typed
  • MALF 2,401 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 256
  • PHOTO Stent

Nearest event-volume peer: Stent, Superficial Femoral Artery, Drug-Eluting (1 report gap)

Nebulizer (Direct Patient Interface) sits #422 of 1000 among tracked device types with 2,847 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Nebulizer carries 9.0% INJURY-coded reports, 21.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.5% corpus 1.5% · near corpus mean (+0.0 pp)
  • INJ 9.0% corpus 30.3% · below corpus mean (-21.3 pp)
  • MALF 84.3% corpus 64.8% · above corpus mean (+19.5 pp)

Lead product-problem code Failure to Deliver is 21% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 88% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Nebulizer in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Nebulizer (Direct Patient Interface) carries 2,847 MAUDE reports, ranked #422 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 2,401 (84.3%)
Injury 257 (9.0%)
Other 94 (3.3%)
52 (1.8%)
Death 43 (1.5%)

Patient Outcomes

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

2,305 (79.7%)
Other 293 (10.1%)
Required Intervention 84 (2.9%)
Hospitalization 82 (2.8%)
Death 44 (1.5%)
R 28 (1.0%)
Life Threatening 23 (0.8%)
O 9 (0.3%)
L 8 (0.3%)
Disability 6 (0.2%)
H 5 (0.2%)
S 5 (0.2%)

Top Product Problems

Failure to Deliver 414
Leak/Splash 217
Connection Problem 171
Infusion or Flow Problem 143
Break 135
Device Operates Differently Than Expected 123
No Flow 85
Disconnection 82
Smoking 65
Inaccurate Delivery 56
Defective Device 54
Tear, Rip or Hole in Device Packaging 53
Fitting Problem 52
Overheating of Device 52
Fire 48
Device Emits Odor 47
Improper Flow or Infusion 47
Melted 46
Fluid/Blood Leak 45
Adverse Event Without Identified Device or Use Problem 38

Yearly Trend

92
1992: 3
93
1993: 2
94
1994: 9
95
1995: 6
96
1996: 6
97
1997: 6
98
1998: 15
99
1999: 17
00
2000: 17
01
2001: 9
02
2002: 9
03
2003: 11
04
2004: 11
05
2005: 5
06
2006: 11
07
2007: 26
08
2008: 11
09
2009: 15
10
2010: 37
11
2011: 237
12
2012: 138
13
2013: 217
14
2014: 123
15
2015: 166
16
2016: 201
17
2017: 256
18
2018: 162
19
2019: 185
20
2020: 117
21
2021: 161
22
2022: 55
23
2023: 107
24
2024: 102
25
2025: 193
26
2026: 201

Reports rose to 193 in 2025, up from an average of 105 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Nebulizer (Direct Patient Interface)

Event Locations

1,495 (52.5%)
I 1,018 (35.8%)
NO INFORMATION 147 (5.2%)
HOSPITAL 115 (4.0%)
HOME 40 (1.4%)
INVALID DATA 7 (0.2%)
UNKNOWN 7 (0.2%)
NURSING HOME 6 (0.2%)
OTHER 5 (0.2%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)
NOT APPLICABLE 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)

Compare TELEFLEX MEDICAL vs RESPIRONICS, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Nebulizer: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,847 here).

Similar death-typed counts

Nearest other device types by death-typed report count (43 here), distinct from the volume row.

Disclaimer: MAUDE figures for Nebulizer are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Nebulizer; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.