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 Class II (moderate risk, special controls required), regulated under 21 CFR §868.5450 (Anesthesiology panel).
FDA MAUDE casebook
openFDA event book Humidifier, Respiratory Gas, MID-BOOK · MAUDE
#153 of 1000 · 18,072 reports · 1992–2026
- BOOK 18,072 reports
- RANK #153 of 1000
- DEATH 126 death-typed
- INJ 407 injury-typed
- MALF 17,345 malfunction
- SPAN 1992–2026
- PEAK 2026: 2,067
- PHOTO Immunoassay Method
Nearest event-volume peer: Immunoassay Method, Troponin Subunit (23 report gap)
Humidifier, Respiratory Gas, (Direct Patient Interface) sits #153 of 1000 among tracked device types with 18,072 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 →
Malfunction reports run above the device-type norm
Humidifier, Respiratory Gas, carries 96.0% MALFUNCTION-coded reports, 31.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
- INJ 2.3% corpus 30.3% · below corpus mean (-28.0 pp)
- MALF 96.0% corpus 64.8% · above corpus mean (+31.1 pp)
Lead product-problem code No Audible Alarm is 29% of coded problems · Lead manufacturer FISHER & PAYKEL HEALTHCARE LTD accounts for 74% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .
Humidifier, Respiratory Gas, in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Device
Device, Incontinence, Mechanical/Hydraulic
18,299 reports
- Phakic Toric…
Phakic Toric Intraocular Lens
18,233 reports
- Motor
Motor, Surgical Instrument, Ac-Powered
18,194 reports
- Immunoassay M…
Immunoassay Method, Troponin Subunit
18,095 reports
- Humidifier (this)
Humidifier, Respiratory Gas, (Direct Patient Interface)
18,072 reports
- Bit, Drill
Bit, Drill
17,754 reports
What this shows Humidifier, Respiratory Gas, (Direct Patient Interface) carries 18,072 MAUDE reports, ranked #153 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 1,759 in 2025, up from an average of 609 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Humidifier, Respiratory Gas, (Direct Patient Interface)
Top Manufacturers
Event Locations
Compare FISHER & PAYKEL HEALTHCARE LTD vs TELEFLEX MEDICAL →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Humidifier, Respiratory Gas,: 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 (18,072 here).
Similar death-typed counts
Nearest other device types by death-typed report count (126 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.