Devices › Analyzer, gas, carbon-dioxide, gaseous-phase
Device brand name · Analyzer gas carbon-dioxide gaseous
Alaris Etco2: medical device reports filed with FDA
259 reports name it, 2020–2021. Manufacturer given most often on reports: Carefusion Sd. Product code CCK.
- 259
- device reports naming the brand
- 0% of all MAUDE reports · about 46 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 100%
- classified as malfunction
- 98.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 259 reports that name the brand "Alaris Etco2" (analyzer gas carbon-dioxide gaseous), received between November 2020 and June 2021; the manufacturer given most often on reports is Carefusion Sd. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in 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 (100%); across all analyzer, gas, carbon-dioxide, gaseous-phase reports (product code CCK) death is recorded in 0.3% and malfunction in 98.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device sensing problem (34%), device alarm system (31.7%) and insufficient device problem information (23.9%). The patient problems coded most often are no patient involvement. 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."
Reports by month, five years
No report naming Alaris Etco2 was received in the five years to August 2026; the latest was received in June 2021.
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 12,829 reports carrying product code CCK. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device sensing problem | 88 | 34% | 1.4% |
| Device alarm system | 82 | 31.7% | 7.5% |
| Insufficient device problem information | 62 | 23.9% | 2.3% |
| Calibration problem | 35 | 13.5% | 5.8% |
| Failure to read input signal | 34 | 13.1% | 0.8% |
| Pumping stopped | 28 | 10.8% | 0.3% |
| Crackthe device cracked | 27 | 10.4% | 21% |
| Communication or transmission problemthe device could not communicate or transmit | 25 | 9.7% | 26.8% |
| Breakthe device broke | 24 | 9.3% | 27.7% |
| Failure to cycle | 19 | 7.3% | 0.2% |
| Failure to calibrate | 10 | 3.9% | 8.9% |
| Contamination | 7 | 2.7% | 4.2% |
| No device output | 6 | 2.3% | 4.4% |
| Display or visual feedback problem | 5 | 1.9% | 0.9% |
| Lack of maintenance documentation or guidelines | 4 | 1.5% | 0% |
| Loose or intermittent connection | 4 | 1.5% | 3.6% |
| Computer software problema software problem | 3 | 1.2% | 4.4% |
| Corrodedthe device corroded | 3 | 1.2% | 8.7% |
| Electrical /electronic property probleman electrical or electronic problem | 3 | 1.2% | 0.2% |
| Physical resistance/sticking | 3 | 1.2% | 1.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 127 | 49% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Alaris Etco2 | Product code CCK | All MAUDE reports |
|---|---|---|---|
| Reports | 259 | 12,829 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 0% | 1% | 36.2% |
| Classified as malfunction | 100% | 98.5% | 62.3% |
| Filed by the manufacturer | 100% | 97.7% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code CCK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Alaris System | 422,501 | 33,692 | 0% |
| 8300 Alaris Etco2 Module | 3,365 | 0 | 0% |
| Gf-210ra | 290 | 0 | 0% |
| Alaris Etco2 Module | 573 | 0 | 0.2% |
| Gf-210r | 171 | 95 | 0% |
| Ag-920ra | 152 | 0 | 0% |
| Nellcor | 1,814 | 215 | 3.9% |
| Versaport Plus | 195 | 5 | 1% |
| Alaris | 1,229 | 79 | 1.1% |
| Covidien | 422 | 30 | 1.4% |
| Philips | 190 | 0 | 6.3% |
| 8100 Alaris Pump Module | 163,620 | 0 | 0% |
| 8120 Alaris Pca | 6,258 | 0 | 0% |
| AirLife | 155 | 37 | 2.6% |
| Alaris Pca | 1,707 | 0 | 0.1% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Alaris Etco2 reports
How many FDA reports name Alaris Etco2?
259 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device sensing problem (34%), device alarm system (31.7%), insufficient device problem information (23.9%), calibration problem (13.5%) and failure to read input signal (13.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Alaris Etco2 was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.