2026 data FDA MAUDE openFDA

Humidifier, Respiratory Gas, (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 MAUDE casebook

openFDA event book Humidifier, Respiratory Gas, MID-BOOK · MAUDE

#153 of 1000 · 16,686 reports · 1992–2026

  • BOOK 16,686 reports
  • RANK #153 of 1000
  • DEATH 124 death-typed
  • INJ 398 injury-typed
  • MALF 15,970 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,759
  • PHOTO Console

Nearest event-volume peer: Console, Heart-Lung Machine, Cardiopulmonary Bypass (47 report gap)

Humidifier, Respiratory Gas, (Direct Patient Interface) sits #153 of 1000 among tracked device types with 16,686 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 2.4% corpus 30.4% · below corpus mean (-28.1 pp)
  • MALF 95.7% corpus 64.5% · above corpus mean (+31.2 pp)

Lead product-problem code No Audible Alarm is 41% of coded problems · Lead manufacturer FISHER & PAYKEL HEALTHCARE LTD accounts for 73% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Humidifier, Respiratory Gas, in the event-volume neighbourhood

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

reports

What this shows Humidifier, Respiratory Gas, (Direct Patient Interface) carries 16,686 MAUDE reports, ranked #153 of 1000.

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

Event Types

Malfunction 15,970 (95.7%)
Injury 398 (2.4%)
Other 126 (0.8%)
Death 124 (0.7%)
68 (0.4%)

Patient Outcomes

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

15,817 (94.4%)
Other 326 (1.9%)
Required Intervention 258 (1.5%)
Death 126 (0.8%)
R 54 (0.3%)
Life Threatening 51 (0.3%)
Hospitalization 49 (0.3%)
L 17 (0.1%)
Disability 16 (0.1%)
O 14 (0.1%)
S 8 (0.0%)
H 7 (0.0%)
Congenital Anomaly 4 (0.0%)
D 2 (0.0%)

Top Product Problems

No Audible Alarm 4,526
Defective Alarm 1,679
Material Split, Cut or Torn 606
Crack 578
Leak/Splash 575
Detachment of Device or Device Component 452
Break 409
Fluid/Blood Leak 391
Insufficient Heating 352
Failure to Power Up 270
Device Alarm System 202
Gas/Air Leak 144
Power Problem 139
Device Operates Differently Than Expected 134
Melted 128
Temperature Problem 109
Mechanical Problem 93
Complete Loss of Power 83
Adverse Event Without Identified Device or Use Problem 72
Disconnection 68

Yearly Trend

92
1992: 3
93
1993: 5
94
1994: 15
95
1995: 10
96
1996: 18
97
1997: 15
98
1998: 31
99
1999: 15
00
2000: 21
01
2001: 42
02
2002: 21
03
2003: 19
04
2004: 24
05
2005: 45
06
2006: 94
07
2007: 365
08
2008: 455
09
2009: 557
10
2010: 560
11
2011: 665
12
2012: 583
13
2013: 718
14
2014: 718
15
2015: 670
16
2016: 1,094
17
2017: 1,007
18
2018: 918
19
2019: 894
20
2020: 1,188
21
2021: 1,510
22
2022: 749
23
2023: 716
24
2024: 501
25
2025: 1,759
26
2026: 681

Related Entities for Humidifier, Respiratory Gas, (Direct Patient Interface)

Event Locations

9,707 (58.2%)
I 6,530 (39.1%)
HOSPITAL 348 (2.1%)
NO INFORMATION 48 (0.3%)
HOME 23 (0.1%)
INVALID DATA 12 (0.1%)
NURSING HOME 6 (0.0%)
NOT APPLICABLE 5 (0.0%)
OTHER 3 (0.0%)
UNKNOWN 3 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)

Compare FISHER & PAYKEL HEALTHCARE LTD vs TELEFLEX MEDICAL →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Humidifier, Respiratory Gas,, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (16,686 here).

Similar death-typed counts

Nearest other device types by death-typed report count (124 here), distinct from the volume row.

Disclaimer: MAUDE figures for Humidifier, Respiratory Gas, 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, Respiratory Gas,; 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.