2026 data FDA MAUDE openFDA FDA Class I

Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §868.5640 (Anesthesiology panel).

FDA MAUDE casebook

openFDA event book Nebulizer, Medicinal, Non-Ventilatory LIGHT-BOOK · MAUDE

#814 of 1000 · 623 reports · 1992–2026

  • BOOK 623 reports
  • RANK #814 of 1000
  • DEATH 2 death-typed
  • INJ 52 injury-typed
  • MALF 425 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 207
  • PHOTO Cable

Nearest event-volume peer: Cable, Transducer And Electrode, Patient, (Including Connector) (1 report gap)

Nebulizer, Medicinal, Non-Ventilatory (Atomizer) sits #814 of 1000 among tracked device types with 623 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, Medicinal, Non-Ventilatory carries 8.3% INJURY-coded reports, 21.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 8.3% corpus 30.3% · below corpus mean (-21.9 pp)
  • MALF 68.2% corpus 64.8% · above corpus mean (+3.4 pp)

Lead product-problem code Detachment Of Device Component is 19% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 100% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Nebulizer, Medicinal, Non-Ventilatory in the event-volume neighbourhood

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

reports

What this shows Nebulizer, Medicinal, Non-Ventilatory (Atomizer) carries 623 MAUDE reports, ranked #814 of 1000.

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

Event Types

Malfunction 425 (68.2%)
135 (21.7%)
Injury 52 (8.3%)
Other 9 (1.4%)
Death 2 (0.3%)

Patient Outcomes

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

360 (53.5%)
Other 206 (30.6%)
Hospitalization 38 (5.6%)
O 35 (5.2%)
Required Intervention 12 (1.8%)
R 8 (1.2%)
L 6 (0.9%)
Life Threatening 5 (0.7%)
Death 2 (0.3%)
S 1 (0.1%)

Top Product Problems

Detachment Of Device Component 141
Device Operates Differently Than Expected 105
Loss of or Failure to Bond 63
Failure to Fire 59
Leak/Splash 54
Break 48
Component Falling 46
Failure to Deliver 38
No Flow 36
Nonstandard Device 22
Detachment of Device or Device Component 21
Complete Blockage 19
Device Inoperable 18
Loose or Intermittent Connection 13
Device Damaged Prior to Use 12
No Device Output 12
Packaging Problem 11
Tear, Rip or Hole in Device Packaging 10
Disconnection 9
Insufficient Flow or Under Infusion 9

Yearly Trend

92
1992: 2
94
1994: 5
95
1995: 7
96
1996: 8
97
1997: 4
98
1998: 3
99
1999: 3
00
2000: 5
01
2001: 3
03
2003: 2
04
2004: 2
05
2005: 1
06
2006: 5
07
2007: 3
08
2008: 5
09
2009: 4
10
2010: 15
11
2011: 10
12
2012: 7
13
2013: 207
14
2014: 98
15
2015: 132
16
2016: 18
17
2017: 13
19
2019: 4
20
2020: 1
21
2021: 2
23
2023: 7
24
2024: 7
25
2025: 30
26
2026: 10

Reports rose to 30 in 2025, up from an average of 7 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Top Manufacturers

Event Locations

403 (64.7%)
HOME 94 (15.1%)
I 82 (13.2%)
HOSPITAL 24 (3.9%)
UNKNOWN 8 (1.3%)
NO INFORMATION 5 (0.8%)
INVALID DATA 3 (0.5%)
OUTPATIENT TREATMENT FACILITY 2 (0.3%)
NURSING HOME 1 (0.2%)
OTHER 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Nebulizer, Medicinal, Non-Ventilatory: 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 (623 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Nebulizer, Medicinal, Non-Ventilatory 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, Medicinal, Non-Ventilatory; 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.