Devices › Analyzer, gas, carbon-dioxide, gaseous-phase
Device brand name · Pump infusion
8300 Alaris Etco2 Module: medical device reports filed with FDA
3,365 reports name it, 2020–2022. Manufacturer given most often on reports: Carefusion Sd. Product code CCK.
- 3,365
- device reports naming the brand
- 0% of all MAUDE reports · about 578 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
3,365 medical device reports received by FDA name the brand "8300 Alaris Etco2 Module" (pump infusion); the manufacturer given most often on reports is Carefusion Sd; received from September 2020 to December 2022. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 crack (35.2%), break (27%) and failure to calibrate (15.3%). 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
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 |
|---|---|---|---|
| Crackthe device cracked | 1,185 | 35.2% | 21% |
| Breakthe device broke | 909 | 27% | 27.7% |
| Failure to calibrate | 516 | 15.3% | 8.9% |
| Contamination | 440 | 13.1% | 4.2% |
| Failure of device to self-test | 440 | 13.1% | 4% |
| Communication or transmission problemthe device could not communicate or transmit | 419 | 12.5% | 26.8% |
| Incorrect, inadequate or imprecise result or readings | 403 | 12% | 6.1% |
| Computer software problema software problem | 325 | 9.7% | 4.4% |
| Corrodedthe device corroded | 286 | 8.5% | 8.7% |
| No device output | 278 | 8.3% | 4.4% |
| Circuit failure | 186 | 5.5% | 2.5% |
| Loose or intermittent connection | 108 | 3.2% | 3.6% |
| Application program freezes or fails to launch | 51 | 1.5% | 0.5% |
| Misassembled | 48 | 1.4% | 0.4% |
| Insufficient device problem information | 36 | 1.1% | 2.3% |
| Failure to read input signal | 23 | 0.7% | 0.8% |
| Naturally worn | 19 | 0.6% | 0.2% |
| Peeled/delaminated | 13 | 0.4% | 0.3% |
| Device sensing problem | 10 | 0.3% | 1.4% |
| Display difficult to read | 9 | 0.3% | 0.6% |
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 | 2,609 | 77.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 8300 Alaris Etco2 Module | Product code CCK | All MAUDE reports |
|---|---|---|---|
| Reports | 3,365 | 12,829 | 26,136,888 |
| Share of that pool | — | 26.2% | 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% |
| Gf-210ra | 290 | 0 | 0% |
| Alaris Etco2 | 259 | 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 8300 Alaris Etco2 Module reports
How many FDA reports name 8300 Alaris Etco2 Module?
3,365 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?
crack (35.2%), break (27%), failure to calibrate (15.3%), contamination (13.1%) and failure of device to self-test (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 8300 Alaris Etco2 Module 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.