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2026 data FDA MAUDE openFDA FDA Class II

Mixer, Breathing Gases, Anesthesia Inhalation

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 §868.5330 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Mixer LIGHT-BOOK · MAUDE

#834 of 1000 · 590 reports · 1992–2026

  • BOOK 590 reports
  • RANK #834 of 1000
  • DEATH 9 death-typed
  • INJ 69 injury-typed
  • MALF 498 malfunction
  • SPAN 1992–2026
  • PEAK 2004: 56
  • PHOTO Centrifuges For Clini…

Nearest event-volume peer: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (2 report gap)

Mixer, Breathing Gases, Anesthesia Inhalation sits #834 of 1000 among tracked device types with 590 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

Mixer carries 84.4% MALFUNCTION-coded reports, 19.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.5% corpus 1.5% · near corpus mean (+0.0 pp)
  • INJ 11.7% corpus 30.3% · below corpus mean (-18.6 pp)
  • MALF 84.4% corpus 64.8% · above corpus mean (+19.6 pp)

Lead product-problem code Device Alarm System is 23% of coded problems · Lead manufacturer CAREFUSION accounts for 44% of manufacturer-tagged reports · Top event location HOSPITAL is 29% of location-tagged rows .

Mixer in the event-volume neighbourhood

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

reports

What this shows Mixer, Breathing Gases, Anesthesia Inhalation carries 590 MAUDE reports, ranked #834 of 1000.

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

Event Types

Malfunction 498 (84.4%)
Injury 69 (11.7%)
9 (1.5%)
Death 9 (1.5%)
Other 5 (0.8%)

Patient Outcomes

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

482 (80.3%)
Required Intervention 58 (9.7%)
Other 31 (5.2%)
Life Threatening 10 (1.7%)
R 8 (1.3%)
Death 8 (1.3%)
S 2 (0.3%)
Hospitalization 1 (0.2%)

Top Product Problems

Device Alarm System 117
No Audible Alarm 59
Inaccurate Delivery 56
Device Operates Differently Than Expected 45
Mechanical Problem 41
Out-Of-Box Failure 26
Defective Alarm 21
Leak/Splash 20
Defective Component 17
Device Issue 17
Alarm, failure of warning 15
Gas Output Problem 13
Misassembled 13
Design/structure problem 11
Other (for use when an appropriate device code cannot be identified) 10
Connection error 8
Display or Visual Feedback Problem 8
Output Problem 8
Excess Flow or Over-Infusion 7
Failure to Deliver 7

Yearly Trend

92
1992: 1
95
1995: 1
96
1996: 5
97
1997: 15
98
1998: 1
99
1999: 2
00
2000: 3
01
2001: 7
02
2002: 54
03
2003: 39
04
2004: 56
05
2005: 4
06
2006: 17
07
2007: 15
08
2008: 20
09
2009: 4
10
2010: 22
11
2011: 11
12
2012: 27
13
2013: 18
14
2014: 11
15
2015: 39
16
2016: 30
17
2017: 22
18
2018: 24
19
2019: 26
20
2020: 15
21
2021: 33
22
2022: 15
23
2023: 19
24
2024: 18
25
2025: 13
26
2026: 3

Reports in 2025 (13) held close to the prior two-year average of 19.

Related Entities for Mixer, Breathing Gases, Anesthesia Inhalation

Top Manufacturers

CAREFUSION 77
VYAIRE MEDICAL 66
CAREFUSION, INC 31

Event Locations

HOSPITAL 169 (28.6%)
138 (23.4%)
I 128 (21.7%)
OTHER 86 (14.6%)
UNKNOWN 55 (9.3%)
NO INFORMATION 7 (1.2%)
INVALID DATA 5 (0.8%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
NURSING HOME 1 (0.2%)

Compare CAREFUSION vs VYAIRE MEDICAL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Mixer: 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 (590 here).

Centrifuges For Clinical Use 592 Unit, X-Ray, Intraoral 592 Chair, Adjustable, Mechanical 586 Mesh, Surgical, Absorbable, Abdominal Hernia 586

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

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

Disclaimer: MAUDE figures for Mixer 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 Mixer; 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.