Analyzer, gas, carbon-dioxide, gaseous-phase: medical device reports filed with FDA

12,829 reports carry this product code, 1994–2026; 22 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

12,829
reports with this product code: 0.1% of all MAUDE reports; 1,296
reports, 12 months to August 2026: 1,399 in the 12 months before; 98.5%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code CCK is FDA's classification for "Analyzer, gas, carbon-dioxide, gaseous-phase" (anesthesiology panel), a class 2 device. 12,829 medical device reports carry this product code, 0.1% of the MAUDE database, from June 1994 to August 2026.

1,296 reports arrived in the 12 months to August 2026, close to the 1,399 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (98.5%), injury (1%) and death (0.3%). 22 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Alaris System	7,005	33,692	0%	99.7%
8300 Alaris Etco2 Module	3,309	0	0%	100%
Gf-210ra	290	0	0%	99.7%
Alaris Etco2	249	0	0%	100%
Alaris Etco2 Module	223	0	0.2%	99.8%
Gf-210r	171	95	0%	100%
Ag-920ra	152	0	0%	100%
Nellcor	35	215	3.9%	89.3%
Versaport Plus	4	5	1%	92.8%
Alaris	3	79	1.1%	85.8%
Covidien	2	30	1.4%	45.5%
Philips	2	0	6.3%	78.9%
8100 Alaris Pump Module	1	0	0%	100%
8120 Alaris Pca	1	0	0%	100%
AirLife	1	37	2.6%	61.3%
Alaris Pca	1	0	0.1%	99.7%
Alaris Pump Module	1	0	0%	99.7%
Alaris Syringe Pump	1	0	0.1%	99.8%
Alaris System Pc Unit	1	0	0%	99.9%
Datascope	1	0	7.3%	40.2%
Screw-Vent Dental Implant	1	0	0%	0.1%
Sensor	1	50	0.3%	59.7%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Carefusion Sd	10,481	81.7%
Nihon Kohden	561	4.4%
Carefusion 303	413	3.2%
St Paul	187	1.5%
Masimo - 15750 Alton Pkwy	68	0.5%
Carefusion	36	0.3%
Nellcor Puritan Bennett	34	0.3%
Philips Medizin Systeme B Blingen	29	0.2%
Covidien/Formerly Tyco Healthcare	12	0.1%
Zoll Medical	9	0.1%
Covidien Formerly Tyco Healthcare	6	0%
Mmj De Cv Usd	6	0%
Philips Medical Systems	5	0%
Alaris Medical Systems	3	0%
Ge Healthcare	3	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.3%34

Injury1%129

Malfunction98.5%12,641

Other0.1%17

Not given0.1%8

Who filed

Manufacturer report97.7%12,536

Voluntary report0.8%106

User facility report0%0

Distributor report0.7%93

Not given0.7%94

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	3,556	27.7%
Communication or transmission problemthe device could not communicate or transmit	3,433	26.8%
Crackthe device cracked	2,698	21%
Failure to calibrate	1,144	8.9%
Corrodedthe device corroded	1,111	8.7%
Device alarm system	964	7.5%
Incorrect, inadequate or imprecise result or readings	787	6.1%
Calibration problem	740	5.8%
No device output	568	4.4%
Computer software problema software problem	564	4.4%
Contamination	545	4.2%
Failure of device to self-test	517	4%
Loose or intermittent connection	466	3.6%
Circuit failure	317	2.5%
Output problem	308	2.4%
Insufficient device problem information	300	2.3%
Device sensing problem	184	1.4%
Unable to obtain readings	169	1.3%
Physical resistance/sticking	141	1.1%
Missing information	124	1%

Questions about analyzer, gas, carbon-dioxide, gaseous-phase reports

What is product code CCK?

FDA's classification code for "Analyzer, gas, carbon-dioxide, gaseous-phase", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

12,829 reports through August 2026, 1,296 of them in the latest 12 months.

Which brands appear most often?

Alaris System (7,005), 8300 Alaris Etco2 Module (3,309), Gf-210ra (290), Alaris Etco2 (249) and Alaris Etco2 Module (223). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.