Devices › Oximeter, tissue saturation
Device brand name · Oximeter tissue saturation
Invos: medical device reports filed with FDA
441 reports name it, 2017–2026. Manufacturer given most often on reports: Nellcor Puritan Bennett Ireland. Product code MUD.
- 441
- device reports naming the brand
- 0% of all MAUDE reports · about 47 a year
- 50
- reports, 12 months to August 2026
- 148 in the 12 months before
- 91.8%
- classified as malfunction
- 90.1% across the product code
- 1.1%
- classified as death, as reported
- 5 reports · not verified by FDA
441 medical device reports received by FDA name the brand "Invos" (oximeter tissue saturation); the manufacturer given most often on reports is Nellcor Puritan Bennett Ireland; received from March 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
50 reports arrived in the 12 months to August 2026, down 66% from 148 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 (91.8%), injury (7%) and death (1.1%); across all oximeter, tissue saturation reports (product code MUD) death is recorded in 0.8% and malfunction in 90.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are low readings (34.5%), incorrect measurement (16.1%) and failure to analyze signal (15.4%). The patient problems coded most often are pressure sore/ulcer, burn(s) and 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 738 reports carrying product code MUD. 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 | 152 | 34.5% | 23.7% |
| Incorrect measurementthe device measured wrongly | 71 | 16.1% | 19% |
| Failure to analyze signal | 68 | 15.4% | 9.5% |
| Communication or transmission problemthe device could not communicate or transmit | 45 | 10.2% | 6.1% |
| Patient device interaction problem | 42 | 9.5% | 7% |
| Manufacturing, packaging or shipping problem | 40 | 9.1% | 5.4% |
| Erratic or intermittent display | 39 | 8.8% | 5.3% |
| High readingsreadings were too high | 39 | 8.8% | 7% |
| Device alarm system | 33 | 7.5% | 4.5% |
| Defective devicethe device was defective | 28 | 6.3% | 4.1% |
| Image display error/artifact | 26 | 5.9% | 3.7% |
| Contamination /decontamination problem | 14 | 3.2% | 1.9% |
| Temperature problem | 10 | 2.3% | 1.2% |
| Device damaged prior to usethe device was damaged before use | 7 | 1.6% | 0.9% |
| Display or visual feedback problem | 7 | 1.6% | 0.9% |
| Failure to power up | 7 | 1.6% | 0.8% |
| Insufficient device problem information | 7 | 1.6% | 3% |
| Material split, cut or torn | 5 | 1.1% | 0.7% |
| Data problem | 4 | 0.9% | 0.5% |
| Incorrect, inadequate or imprecise result or readings | 4 | 0.9% | 14.5% |
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 |
|---|---|---|
| Pressure sore/ulcer | 20 | 4.5% |
| Burn(s)a burn | 16 | 3.6% |
| No patient involvement | 14 | 3.2% |
| Injurya physical injury | 8 | 1.8% |
| Skin irritationirritated skin | 5 | 1.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 0.9% |
| Deaththe patient died; cause not stated by this term | 4 | 0.9% |
| Infarction, cerebral | 3 | 0.7% |
| Inflammationinflammation | 3 | 0.7% |
| Superficial (first degree) burn | 3 | 0.7% |
| Rashskin rash | 2 | 0.5% |
| Stroke/cva | 2 | 0.5% |
| Bruise/contusion | 1 | 0.2% |
| Ecchymosis | 1 | 0.2% |
| Hemorrhage, cerebral | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Invos | Product code MUD | All MAUDE reports |
|---|---|---|---|
| Reports | 441 | 738 | 26,136,888 |
| Share of that pool | — | 59.8% | 0% |
| Classified as death, per 1,000 reports | 11 | 8 | 9 |
| Classified as injury | 7% | 7.5% | 36.2% |
| Classified as malfunction | 91.8% | 90.1% | 62.3% |
| Filed by the manufacturer | 99.1% | 95.1% | 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."
Questions about Invos reports
How many FDA reports name Invos?
441 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 50 in the latest 12 months.
What kinds of events are reported?
malfunction (91.8%), injury (7%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
low readings (34.5%), incorrect measurement (16.1%), failure to analyze signal (15.4%), communication or transmission problem (10.2%) and patient device interaction problem (9.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.1%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Invos 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.