Device brand name · Oximeter
Nellcor: medical device reports filed with FDA
1,814 reports name it, 1997–2026. Manufacturer given most often on reports: Mediana. Product code DQA.
- 1,814
- device reports naming the brand
- 0% of all MAUDE reports · about 62 a year
- 215
- reports, 12 months to August 2026
- 241 in the 12 months before
- 89.3%
- classified as malfunction
- 91.6% across the product code
- 3.9%
- classified as death, as reported
- 71 reports · not verified by FDA
1,814 medical device reports received by FDA name the brand "Nellcor" (oximeter); the manufacturer given most often on reports is Mediana; received from January 1997 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
215 reports arrived in the 12 months to August 2026, down 11% from 241 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 (89.3%), injury (6.5%) and death (3.9%); across all oximeter reports (product code DQA) death is recorded in 2.6% and malfunction in 91.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are low readings (19.8%), incorrect measurement (13%) and device alarm system (12.7%). The patient problems coded most often are no patient involvement, burn(s) and pressure sore/ulcer. 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 14,003 reports carrying product code DQA. 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 |
|---|---|---|---|
| Low readingsreadings were too low | 359 | 19.8% | 5.3% |
| Incorrect measurementthe device measured wrongly | 235 | 13% | 16.6% |
| Device alarm system | 231 | 12.7% | 5.2% |
| Image display error/artifact | 173 | 9.5% | 1.8% |
| Patient device interaction problem | 149 | 8.2% | 1.1% |
| Failure to analyze signal | 127 | 7% | 1% |
| High readingsreadings were too high | 120 | 6.6% | 3.3% |
| Display or visual feedback problem | 104 | 5.7% | 7.9% |
| Temperature problem | 104 | 5.7% | 0.9% |
| Nonstandard device | 73 | 4% | 0.7% |
| Component missing | 71 | 3.9% | 2.3% |
| No display/image | 71 | 3.9% | 2.8% |
| Contamination /decontamination problem | 51 | 2.8% | 0.4% |
| Erratic or intermittent display | 45 | 2.5% | 1% |
| Device operates differently than expectedthe device behaved unexpectedly | 41 | 2.3% | 5.9% |
| Failure to power up | 32 | 1.8% | 0.9% |
| Delayed program or algorithm execution | 28 | 1.5% | 0.2% |
| Noise, audible | 28 | 1.5% | 0.3% |
| Insufficient device problem information | 24 | 1.3% | 0.8% |
| Poor quality image | 22 | 1.2% | 0.3% |
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 | 256 | 14.1% |
| Burn(s)a burn | 68 | 3.7% |
| Pressure sore/ulcer | 58 | 3.2% |
| Low oxygen saturation | 40 | 2.2% |
| Deaththe patient died; cause not stated by this term | 34 | 1.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 25 | 1.4% |
| Injurya physical injury | 22 | 1.2% |
| Blistera blister | 18 | 1% |
| Skin irritationirritated skin | 15 | 0.8% |
| Tissue damage | 13 | 0.7% |
| Skin inflammation/ irritation | 11 | 0.6% |
| Cyanosis | 8 | 0.4% |
| Unintended extubation | 7 | 0.4% |
| Inflammationinflammation | 6 | 0.3% |
| Burn, thermal | 5 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Nellcor | Product code DQA | All MAUDE reports |
|---|---|---|---|
| Reports | 1,814 | 14,003 | 26,136,888 |
| Share of that pool | — | 13% | 0% |
| Classified as death, per 1,000 reports | 39 | 26 | 9 |
| Classified as injury | 6.5% | 4.2% | 36.2% |
| Classified as malfunction | 89.3% | 91.6% | 62.3% |
| Filed by the manufacturer | 95.8% | 94.9% | 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 DQA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Heartstart Sla Battery | 981 | 0 | 0.1% |
| Rad-8 Horizontal | 625 | 0 | 2.4% |
| Radical-7 Handheld | 534 | 0 | 1.3% |
| Radical-7 | 516 | 79 | 1.7% |
| N595 Pulse Oximeter | 513 | 0 | 0% |
| Oximax N-595 Pulse Oximeter | 417 | 0 | 0.5% |
| Rad-8 | 400 | 0 | 3.5% |
| Rad-57 | 221 | 9 | 0% |
| Nellcor Oximax N-65 | 200 | 0 | 0% |
| EarlyVue VS30 | 191 | 181 | 0% |
| Oximax N-560 Pulse Oximeter | 212 | 0 | 4.7% |
| Nellcor N595 Pulse Oximeter | 157 | 0 | 0% |
| Sensor | 1,053 | 50 | 0.3% |
| Respironics | 17,693 | 2,239 | 0.3% |
| Codemaster Xl | 427 | 0 | 2.1% |
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 Nellcor reports
How many FDA reports name Nellcor?
1,814 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 215 in the latest 12 months.
What kinds of events are reported?
malfunction (89.3%), injury (6.5%) and death (3.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
low readings (19.8%), incorrect measurement (13%), device alarm system (12.7%), image display error/artifact (9.5%) and patient device interaction problem (8.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.8%) and voluntary reports (1.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Nellcor 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.