2026 data FDA MAUDE openFDA FDA Class II

Gas-Machine, Anesthesia

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 §868.5160 (Anesthesiology panel).

FDA MAUDE casebook

openFDA event book Gas-Machine, Anesthesia MID-BOOK · MAUDE

#74 of 1000 · 47,945 reports · 1992–2026

  • BOOK 47,945 reports
  • RANK #74 of 1000
  • DEATH 112 death-typed
  • INJ 722 injury-typed
  • MALF 46,916 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 9,366
  • PHOTO Sv70 Ventilator

Nearest event-volume peer: Sv70 Ventilator (90 report gap)

Gas-Machine, Anesthesia sits #74 of 1000 among tracked device types with 47,945 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

Gas-Machine, Anesthesia carries 97.9% MALFUNCTION-coded reports, 33.0pp above 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 1.5% corpus 30.3% · below corpus mean (-28.8 pp)
  • MALF 97.9% corpus 64.8% · above corpus mean (+33.0 pp)

Lead product-problem code Therapeutic or Diagnostic Output Failure is 17% of coded problems · Lead manufacturer DATEX-OHMEDA, INC. accounts for 75% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

Gas-Machine, Anesthesia in the event-volume neighbourhood

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

reports

What this shows Gas-Machine, Anesthesia carries 47,945 MAUDE reports, ranked #74 of 1000.

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

Event Types

Malfunction 46,916 (97.9%)
Injury 722 (1.5%)
Other 121 (0.3%)
Death 112 (0.2%)
74 (0.2%)

Patient Outcomes

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

46,512 (97.2%)
Other 469 (1.0%)
Required Intervention 333 (0.7%)
Life Threatening 201 (0.4%)
Death 112 (0.2%)
Hospitalization 65 (0.1%)
R 56 (0.1%)
Disability 33 (0.1%)
L 30 (0.1%)
O 27 (0.1%)
S 25 (0.1%)
H 2 (0.0%)
Invalid Data 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Therapeutic or Diagnostic Output Failure 7,031
Mechanical Problem 4,765
No Flow 4,232
Failure to Run on Battery 3,959
Insufficient Flow or Under Infusion 2,520
Device Operates Differently Than Expected 1,792
No Display/Image 1,774
Power Problem 1,642
Unexpected Therapeutic Results 1,430
Electrical /Electronic Property Problem 1,416
Failure to Deliver 1,401
Gas/Air Leak 1,329
Output Problem 1,286
Appropriate Device Problem Term/Code Not Available 1,222
Gas Output Problem 1,119
Increase in Pressure 1,089
Unexpected Shutdown 941
Device Displays Incorrect Message 855
Infusion or Flow Problem 798
Leak/Splash 769

Yearly Trend

92
1992: 3
93
1993: 5
94
1994: 8
95
1995: 13
96
1996: 15
97
1997: 28
98
1998: 27
99
1999: 45
00
2000: 141
01
2001: 116
02
2002: 99
03
2003: 149
04
2004: 147
05
2005: 159
06
2006: 107
07
2007: 132
08
2008: 104
09
2009: 85
10
2010: 97
11
2011: 87
12
2012: 89
13
2013: 308
14
2014: 279
15
2015: 572
16
2016: 2,135
17
2017: 2,355
18
2018: 2,589
19
2019: 1,957
20
2020: 2,687
21
2021: 3,123
22
2022: 4,352
23
2023: 5,595
24
2024: 6,067
25
2025: 9,366
26
2026: 4,904

Reports rose to 9,366 in 2025, up from an average of 5,831 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Gas-Machine, Anesthesia

Event Locations

32,354 (67.5%)
I 14,072 (29.4%)
HOSPITAL 1,271 (2.7%)
NO INFORMATION 187 (0.4%)
UNKNOWN 18 (0.0%)
AMBULATORY SURGICAL FACILITY 14 (0.0%)
INVALID DATA 10 (0.0%)
NOT APPLICABLE 8 (0.0%)
OTHER 7 (0.0%)
HOME 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare DATEX-OHMEDA, INC. vs GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Gas-Machine, Anesthesia: 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 (47,945 here).

Similar death-typed counts

Nearest other device types by death-typed report count (112 here), distinct from the volume row.

Disclaimer: MAUDE figures for Gas-Machine, Anesthesia 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 Gas-Machine, Anesthesia; 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.