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2026 data FDA MAUDE openFDA FDA Class I

Humidifier, Non-Direct Patient Interface (Home-Use)

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 §868.5460 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Humidifier, Non-Direct Patient Interface LIGHT-BOOK · MAUDE

#732 of 1000 · 801 reports · 1994–2026

  • BOOK 801 reports
  • RANK #732 of 1000
  • DEATH 2 death-typed
  • INJ 193 injury-typed
  • MALF 484 malfunction
  • SPAN 1994–2026
  • PEAK 2017: 93
  • PHOTO Heparin

Nearest event-volume peer: Heparin, Vascular Access Flush (1 report gap)

Humidifier, Non-Direct Patient Interface (Home-Use) sits #732 of 1000 among tracked device types with 801 MAUDE reports spanning 1994–2026. 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Humidifier, Non-Direct Patient Interface carries 24.1% INJURY-coded reports, 6.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 24.1% corpus 30.3% · below corpus mean (-6.2 pp)
  • MALF 60.4% corpus 64.8% · below corpus mean (-4.4 pp)

Lead product-problem code Fire is 31% of coded problems · Top event location is 49% of location-tagged rows .

Humidifier, Non-Direct Patient Interface in the event-volume neighbourhood

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

reports

What this shows Humidifier, Non-Direct Patient Interface (Home-Use) carries 801 MAUDE reports, ranked #732 of 1000.

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

Event Types

Malfunction 484 (60.4%)
Injury 193 (24.1%)
Other 100 (12.5%)
22 (2.7%)
Death 2 (0.2%)

Patient Outcomes

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

511 (55.8%)
Other 214 (23.4%)
R 66 (7.2%)
O 38 (4.1%)
Hospitalization 37 (4.0%)
Required Intervention 29 (3.2%)
H 9 (1.0%)
S 5 (0.5%)
Disability 4 (0.4%)
Death 2 (0.2%)
Life Threatening 1 (0.1%)

Top Product Problems

Fire 306
Smoking 109
Melted 75
Use of Device Problem 68
Improper or Incorrect Procedure or Method 49
Thermal Decomposition of Device 45
Fluid/Blood Leak 40
Adverse Event Without Identified Device or Use Problem 39
Patient Device Interaction Problem 36
Device Emits Odor 33
Labelling, Instructions for Use or Training Problem 29
Overheating of Device 27
Break 22
Device Handling Problem 22
Sparking 20
Human-Device Interface Problem 18
Device Operates Differently Than Expected 17
Unknown (for use when the device problem is not known) 17
Device Tipped Over 15
Burst Container or Vessel 14

Yearly Trend

94
1994: 2
95
1995: 1
96
1996: 5
97
1997: 10
98
1998: 7
99
1999: 4
00
2000: 9
01
2001: 11
02
2002: 10
03
2003: 12
04
2004: 3
05
2005: 2
06
2006: 4
07
2007: 6
08
2008: 5
09
2009: 6
10
2010: 13
11
2011: 13
12
2012: 17
13
2013: 71
14
2014: 90
15
2015: 77
16
2016: 84
17
2017: 93
18
2018: 59
19
2019: 41
20
2020: 32
21
2021: 32
22
2022: 24
23
2023: 22
24
2024: 13
25
2025: 16
26
2026: 7

Reports in 2025 (16) held close to the prior two-year average of 18.

Related Entities for Humidifier, Non-Direct Patient Interface (Home-Use)

Event Locations

394 (49.2%)
I 300 (37.5%)
HOME 52 (6.5%)
NO INFORMATION 44 (5.5%)
OTHER 4 (0.5%)
NOT APPLICABLE 3 (0.4%)
UNKNOWN 2 (0.2%)
NURSING HOME 1 (0.1%)
PUBLIC VENUE 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Humidifier, Non-Direct Patient Interface: 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 (801 here).

Heparin, Vascular Access Flush 800 Tray 800 Drape, Surgical, Antimicrobial 803 Electrode, Electrosurgical 798

Similar death-typed counts

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

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Humidifier, Non-Direct Patient Interface 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, Non-Direct Patient Interface; 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.