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2026 data FDA MAUDE openFDA FDA Class II

Vaporizer, Anesthesia, Non-Heated

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 §868.5880 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Vaporizer, Anesthesia, Non-Heated LIGHT-BOOK · MAUDE

#337 of 1000 · 4,534 reports · 1992–2026

  • BOOK 4,534 reports
  • RANK #337 of 1000
  • DEATH 2 death-typed
  • INJ 73 injury-typed
  • MALF 4,420 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 2,714
  • PHOTO Fluorometer

Nearest event-volume peer: Fluorometer, For Clinical Use (15 report gap)

Vaporizer, Anesthesia, Non-Heated sits #337 of 1000 among tracked device types with 4,534 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

Vaporizer, Anesthesia, Non-Heated carries 97.5% MALFUNCTION-coded reports, 32.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 1.6% corpus 30.3% · below corpus mean (-28.7 pp)
  • MALF 97.5% corpus 64.8% · above corpus mean (+32.7 pp)

Lead product-problem code Output below Specifications is 73% of coded problems · Lead manufacturer DATEX-OHMEDA, INC. accounts for 99% of manufacturer-tagged reports · Top event location is 87% of location-tagged rows .

Vaporizer, Anesthesia, Non-Heated in the event-volume neighbourhood

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

reports

What this shows Vaporizer, Anesthesia, Non-Heated carries 4,534 MAUDE reports, ranked #337 of 1000.

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

Event Types

Malfunction 4,420 (97.5%)
Injury 73 (1.6%)
Other 24 (0.5%)
15 (0.3%)
Death 2 (0.0%)

Patient Outcomes

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

4,326 (95.3%)
Other 133 (2.9%)
Required Intervention 49 (1.1%)
Life Threatening 8 (0.2%)
R 6 (0.1%)
Hospitalization 5 (0.1%)
Disability 4 (0.1%)
L 3 (0.1%)
S 2 (0.0%)
Death 2 (0.0%)

Top Product Problems

Output below Specifications 3,134
Insufficient Flow or Under Infusion 193
Output, high 172
Output, low 151
Infusion or Flow Problem 106
Output above Specifications 65
Inaccurate Delivery 48
Improper Flow or Infusion 45
Leak/Splash 45
Sharp/jagged/rough/etched/scratched 40
Gas Output Problem 32
No Device Output 31
Excess Flow or Over-Infusion 30
Device Operates Differently Than Expected 29
Other (for use when an appropriate device code cannot be identified) 28
Valve(s), defective 25
Component Missing 24
Design/structure problem 23
Device Inoperable 22
Use of Device Problem 22

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 8
95
1995: 10
96
1996: 58
97
1997: 104
98
1998: 83
99
1999: 33
00
2000: 61
01
2001: 76
02
2002: 57
03
2003: 50
04
2004: 65
05
2005: 52
06
2006: 47
07
2007: 30
08
2008: 29
09
2009: 39
10
2010: 32
11
2011: 41
12
2012: 14
13
2013: 12
14
2014: 5
15
2015: 41
16
2016: 9
17
2017: 14
18
2018: 11
19
2019: 12
20
2020: 11
21
2021: 12
22
2022: 13
23
2023: 44
24
2024: 255
25
2025: 2,714
26
2026: 490

Reports rose to 2,714 in 2025, up from an average of 150 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Vaporizer, Anesthesia, Non-Heated

Top Manufacturers

DATEX-OHMEDA, INC. 3,614
DATEX-OHMEDA INC. 32
DATEX-OHMEDA, INC 22

Event Locations

3,961 (87.4%)
HOSPITAL 386 (8.5%)
I 87 (1.9%)
INVALID DATA 77 (1.7%)
NO INFORMATION 10 (0.2%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
OTHER 3 (0.1%)
UNKNOWN 3 (0.1%)
NOT APPLICABLE 2 (0.0%)
HOME 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare DATEX-OHMEDA, INC. vs DATEX-OHMEDA INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Vaporizer, Anesthesia, Non-Heated: 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 (4,534 here).

Fluorometer, For Clinical Use 4,519 Stimulator, Peripheral Nerve, Implanted 4,474 Broach 4,622 Computer, Diagnostic, Programmable 4,441

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Vaporizer, Anesthesia, Non-Heated 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 Vaporizer, Anesthesia, Non-Heated; 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.