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2026 data FDA MAUDE openFDA FDA Class II

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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 §868.1400 (Anesthesiology panel).

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FDA MAUDE casebook

openFDA event book Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase MID-BOOK · MAUDE

#192 of 1000 · 12,717 reports · 1994–2026

  • BOOK 12,717 reports
  • RANK #192 of 1000
  • DEATH 34 death-typed
  • INJ 129 injury-typed
  • MALF 12,529 malfunction
  • SPAN 1994–2026
  • PEAK 2022: 2,475
  • PHOTO Recorder

Nearest event-volume peer: Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (9 report gap)

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase sits #192 of 1000 among tracked device types with 12,717 MAUDE reports spanning 1994–2026. 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

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase carries 98.5% MALFUNCTION-coded reports, 33.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 1.0% corpus 30.3% · below corpus mean (-29.3 pp)
  • MALF 98.5% corpus 64.8% · above corpus mean (+33.7 pp)

Lead product-problem code Break is 18% of coded problems · Lead manufacturer CAREFUSION SD accounts for 90% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase in the event-volume neighbourhood

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

reports

What this shows Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase carries 12,717 MAUDE reports, ranked #192 of 1000.

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

Event Types

Malfunction 12,529 (98.5%)
Injury 129 (1.0%)
Death 34 (0.3%)
Other 17 (0.1%)
8 (0.1%)

Patient Outcomes

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

12,378 (97.7%)
Other 98 (0.8%)
Required Intervention 73 (0.6%)
Death 37 (0.3%)
Life Threatening 34 (0.3%)
R 31 (0.2%)
Hospitalization 9 (0.1%)
H 3 (0.0%)
Disability 3 (0.0%)
O 2 (0.0%)
S 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 3,552
Communication or Transmission Problem 3,403
Crack 2,696
Failure to Calibrate 1,135
Corroded 1,106
Appropriate Device Problem Term/Code Not Available 948
Device Alarm System 943
Incorrect, Inadequate or Imprecise Result or Readings 782
Calibration Problem 732
Computer Software Problem 566
No Device Output 563
Contamination 546
Failure of Device to Self-Test 510
Loose or Intermittent Connection 467
No Apparent Adverse Event 428
Circuit Failure 317
Output Problem 302
Insufficient Device Problem Information 301
Device Sensing Problem 187
Unable to Obtain Readings 173

Yearly Trend

94
1994: 2
95
1995: 1
96
1996: 7
97
1997: 5
98
1998: 5
99
1999: 2
00
2000: 3
01
2001: 1
02
2002: 7
03
2003: 3
04
2004: 51
05
2005: 16
06
2006: 22
07
2007: 7
08
2008: 20
09
2009: 21
10
2010: 12
11
2011: 18
12
2012: 13
13
2013: 28
14
2014: 51
15
2015: 114
16
2016: 88
17
2017: 58
18
2018: 63
19
2019: 141
20
2020: 2,302
21
2021: 2,272
22
2022: 2,475
23
2023: 1,637
24
2024: 1,216
25
2025: 1,274
26
2026: 782

Reports in 2025 (1,274) held close to the prior two-year average of 1,427.

Related Entities for Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Top Manufacturers

CAREFUSION SD 10,481
NIHON KOHDEN CORPORATION 513
CAREFUSION 303, INC. 335
ST PAUL 188
SMITHS MEDICAL ASD, INC. 72

Event Locations

8,273 (65.1%)
I 3,992 (31.4%)
HOSPITAL 419 (3.3%)
NO INFORMATION 13 (0.1%)
OTHER 6 (0.0%)
NOT APPLICABLE 5 (0.0%)
INVALID DATA 4 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare CAREFUSION SD vs NIHON KOHDEN CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: 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 (12,717 here).

Recorder, Event, Implantable Cardiac, 12,726 Shoulder Prosthesis, Reverse Configuration 12,771 Electrode, Ph, Stomach 12,853 Clamp, Vascular 12,982

Similar death-typed counts

Nearest other device types by death-typed report count (34 here), distinct from the volume row.

Insufflator, Laparoscopic 34 Intrasaccular Flow Disruption Device 34 Prosthesis 34 Ventilator, Emergency, Powered 34

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

Disclaimer: MAUDE figures for Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 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 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; 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.