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2026 data FDA MAUDE openFDA FDA Class II

Humidifier Nebulizer Kit

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 §868.5450 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Humidifier Nebulizer Kit LIGHT-BOOK · MAUDE

#768 of 1000 · 723 reports · 2015–2026

  • BOOK 723 reports
  • RANK #768 of 1000
  • DEATH 3 death-typed
  • INJ 53 injury-typed
  • MALF 667 malfunction
  • SPAN 2015–2026
  • PEAK 2016: 164
  • PHOTO System

Nearest event-volume peer: System, Imaging, Gastrointestinal, Wireless, Capsule (0 report gap)

Humidifier Nebulizer Kit sits #768 of 1000 among tracked device types with 723 MAUDE reports spanning 2015–2026. 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 →

Malfunction reports run above the device-type norm

Humidifier Nebulizer Kit carries 92.3% MALFUNCTION-coded reports, 27.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 7.3% corpus 30.3% · below corpus mean (-23.0 pp)
  • MALF 92.3% corpus 64.8% · above corpus mean (+27.4 pp)

Lead product-problem code Leak/Splash is 17% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 90% of manufacturer-tagged reports · Top event location I is 89% of location-tagged rows .

Humidifier Nebulizer Kit in the event-volume neighbourhood

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

reports

What this shows Humidifier Nebulizer Kit carries 723 MAUDE reports, ranked #768 of 1000.

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

Event Types

Malfunction 667 (92.3%)
Injury 53 (7.3%)
Death 3 (0.4%)

Patient Outcomes

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

654 (89.8%)
Other 33 (4.5%)
Required Intervention 28 (3.8%)
R 4 (0.5%)
Death 3 (0.4%)
Life Threatening 3 (0.4%)
Hospitalization 2 (0.3%)
L 1 (0.1%)

Top Product Problems

Leak/Splash 125
Connection Problem 112
Device Operates Differently Than Expected 81
Failure to Deliver 64
Gas/Air Leak 60
Melted 54
Overfill 40
Crack 29
Fluid/Blood Leak 24
Break 23
Improper Flow or Infusion 22
Fitting Problem 21
Overheating of Device 20
Temperature Problem 20
No Flow 13
Appropriate Device Problem Term/Code Not Available 12
Mechanical Problem 10
Disconnection 7
Adverse Event Without Identified Device or Use Problem 6
Circuit Failure 6

Yearly Trend

15
2015: 19
16
2016: 164
17
2017: 91
18
2018: 117
19
2019: 109
20
2020: 92
21
2021: 62
22
2022: 14
23
2023: 9
24
2024: 8
25
2025: 11
26
2026: 27

Reports in 2025 (11) held close to the prior two-year average of 9.

Related Entities for Humidifier Nebulizer Kit

Top Manufacturers

TELEFLEX MEDICAL 509
MEDLINE INDUSTRIES, LP 35
MEDLINE INDUSTRIES LP 15
SMITH & NEPHEW, INC. 3
VYAIRE MEDICAL 2
CAREFUSION, INC 1

Event Locations

I 643 (88.9%)
76 (10.5%)
HOSPITAL 3 (0.4%)
NO INFORMATION 1 (0.1%)

Compare TELEFLEX MEDICAL vs MEDLINE INDUSTRIES, LP →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Humidifier Nebulizer Kit: 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 (723 here).

System 723 Apparatus, Exhaust, Surgical 720 Radioimmunoassay, Estradiol 719 Carboxymethylcellulose Sodium Or Polyvinyl… 729

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Humidifier Nebulizer Kit 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 Humidifier Nebulizer Kit; 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.