Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
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 §868.5270 (Anesthesiology panel).
FDA MAUDE casebook
openFDA event book Heater LIGHT-BOOK · MAUDE
#371 of 1000 · 3,525 reports · 1992–2026
- BOOK 3,525 reports
- RANK #371 of 1000
- DEATH 11 death-typed
- INJ 110 injury-typed
- MALF 3,367 malfunction
- SPAN 1992–2026
- PEAK 2013: 387
- PHOTO Extractor
Nearest event-volume peer: Extractor (38 report gap)
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer sits #371 of 1000 among tracked device types with 3,525 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
Heater carries 95.5% MALFUNCTION-coded reports, 30.7pp above 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 3.1% corpus 30.3% · below corpus mean (-27.2 pp)
- MALF 95.5% corpus 64.8% · above corpus mean (+30.7 pp)
Lead product-problem code Leak/Splash is 21% of coded problems · Lead manufacturer FISHER & PAYKEL HEALTHCARE LTD accounts for 75% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .
Heater in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Test, Human Chorionic Gonadotropin
3,570 reports
- Heater (this)
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
3,525 reports
- Extractor
Extractor
3,487 reports
- Stimulator
Stimulator, Hypoglossal Nerve, Implanted, Apnea
3,486 reports
- Control
Control, Pump Speed, Cardiopulmonary Bypass
3,469 reports
- Catheters
Catheters, Suction, Tracheobronchial
3,457 reports
What this shows Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer carries 3,525 MAUDE reports, ranked #371 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 in 2025 (195) held close to the prior two-year average of 149.
Related Entities for Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Top Manufacturers
Event Locations
Compare FISHER & PAYKEL HEALTHCARE LTD vs FISHER & PAYKEL HEALTHCARE, LTD. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Heater: 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 (3,525 here).
Similar death-typed counts
Nearest other device types by death-typed report count (11 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Heater 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 Heater; 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.