2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Heater LIGHT-BOOK · MAUDE

#368 of 1000 · 3,442 reports · 1992–2026

  • BOOK 3,442 reports
  • RANK #368 of 1000
  • DEATH 11 death-typed
  • INJ 109 injury-typed
  • MALF 3,285 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 387
  • PHOTO Catheters

Nearest event-volume peer: Catheters, Suction, Tracheobronchial (23 report gap)

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer sits #368 of 1000 among tracked device types with 3,442 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 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 3.2% corpus 30.4% · below corpus mean (-27.3 pp)
  • MALF 95.4% corpus 64.5% · above corpus mean (+30.9 pp)

Lead product-problem code Leak/Splash is 22% of coded problems · Lead manufacturer FISHER & PAYKEL HEALTHCARE LTD accounts for 74% of manufacturer-tagged reports · Top event location is 72% of location-tagged rows .

Heater in the event-volume neighbourhood

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

reports

What this shows Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer carries 3,442 MAUDE reports, ranked #368 of 1000.

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

Event Types

Malfunction 3,285 (95.4%)
Injury 109 (3.2%)
19 (0.6%)
Other 18 (0.5%)
Death 11 (0.3%)

Patient Outcomes

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

3,183 (92.0%)
Other 115 (3.3%)
Required Intervention 111 (3.2%)
R 13 (0.4%)
Death 12 (0.3%)
Life Threatening 11 (0.3%)
Hospitalization 6 (0.2%)
L 3 (0.1%)
S 2 (0.1%)
O 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Leak/Splash 398
Gas/Air Leak 332
Crack 328
Insufficient Heating 138
Temperature Problem 88
Disconnection 84
Break 74
Fluid/Blood Leak 53
Connection Problem 48
Material Split, Cut or Torn 42
Therapeutic or Diagnostic Output Failure 42
Device Issue 32
Moisture or Humidity Problem 32
Failure of Device to Self-Test 30
Loose or Intermittent Connection 29
Material Puncture/Hole 22
Detachment of Device or Device Component 19
Incorrect, Inadequate or Imprecise Result or Readings 19
Melted 18
Mechanical Problem 15

Yearly Trend

92
1992: 2
93
1993: 1
94
1994: 2
97
1997: 1
98
1998: 2
99
1999: 16
00
2000: 11
01
2001: 32
02
2002: 8
03
2003: 10
04
2004: 9
05
2005: 7
06
2006: 6
07
2007: 69
08
2008: 74
09
2009: 80
10
2010: 126
11
2011: 192
12
2012: 334
13
2013: 387
14
2014: 338
15
2015: 155
16
2016: 212
17
2017: 209
18
2018: 103
19
2019: 134
20
2020: 123
21
2021: 124
22
2022: 152
23
2023: 125
24
2024: 172
25
2025: 195
26
2026: 31

Related Entities for Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Event Locations

2,481 (72.1%)
I 884 (25.7%)
HOSPITAL 63 (1.8%)
NO INFORMATION 10 (0.3%)
HOME 2 (0.1%)
NOT APPLICABLE 1 (0.0%)
OTHER 1 (0.0%)

Compare FISHER & PAYKEL HEALTHCARE LTD vs FISHER & PAYKEL HEALTHCARE, LTD. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Heater, 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 (3,442 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

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.