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Vaporizer, Anesthesia, Non-Heated

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Vaporizer, Anesthesia, Non-Heated

The FDA MAUDE database aggregates 4,162 adverse-event reports for Vaporizer, Anesthesia, Non-Heated spanning the period from 1992 through 2026. Of these, 2 are classified as death reports, 71 as injury reports, and 4,050 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 10 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Output below Specifications topping the list at 2,782 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 2,714 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 11 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

4,162
Total Reports
2
Death Reports
71
Injury Reports
4,050
Malfunctions

Event Types

Malfunction 4,050 (97.3%)
Injury 71 (1.7%)
Other 24 (0.6%)
15 (0.4%)
Death 2 (0.0%)

Patient Outcomes

3,960 (95.0%)
Other 132 (3.2%)
Required Intervention 48 (1.2%)
Life Threatening 8 (0.2%)
R 6 (0.1%)
Disability 4 (0.1%)
Hospitalization 4 (0.1%)
L 3 (0.1%)
S 2 (0.0%)
Death 2 (0.0%)

Top Product Problems

Output below Specifications 2,782
Insufficient Flow or Under Infusion 172
Infusion or Flow Problem 101
Improper Flow or Infusion 44
Inaccurate Delivery 26
Unexpected Therapeutic Results 21
Excess Flow or Over-Infusion 20
No Apparent Adverse Event 11
Detachment of Device or Device Component 10
Output above Specifications 10
Low Readings 9
Mechanical Problem 7
Therapeutic or Diagnostic Output Failure 7
Device Operates Differently Than Expected 6
Gas Output Problem 6
Appropriate Term/Code Not Available 5
High Readings 5
Insufficient Information 5
Failure to Deliver 4
Gas/Air Leak 4

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: 118

Related Entities for Vaporizer, Anesthesia, Non-Heated

Event Locations

3,590 (86.3%)
HOSPITAL 385 (9.3%)
I 87 (2.1%)
INVALID DATA 77 (1.9%)
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%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.