Devices › Apparatus, nitric oxide delivery
Device brand name · Nitric oxide administration apparatus
INOmax DSIR Plus (Delivery System): medical device reports filed with FDA
714 reports name it, 2019–2026. Manufacturer given most often on reports: Mallinckrodt Manufacturing. Product code MRN.
- 714
- device reports naming the brand
- 0% of all MAUDE reports · about 107 a year
- 53
- reports, 12 months to August 2026
- 97 in the 12 months before
- 98.3%
- classified as malfunction
- 89.5% across the product code
- 0.3%
- classified as death, as reported
- 2 reports · not verified by FDA
714 medical device reports received by FDA name the brand "INOmax DSIR Plus (Delivery System)" (nitric oxide administration apparatus); the manufacturer given most often on reports is Mallinckrodt Manufacturing; received from November 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
53 reports arrived in the 12 months to August 2026, down 45% from 97 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 (98.3%), injury (1.4%) and death (0.3%); across all apparatus, nitric oxide delivery reports (product code MRN) death is recorded in 1.5% and malfunction in 89.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are high readings (31.1%), failure to recalibrate (30.7%) and intermittent communication failure (29.3%). The patient problems coded most often are low oxygen saturation, bradycardia and hypoxia. 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 2,059 reports carrying product code MRN. 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 |
|---|---|---|---|
| High readingsreadings were too high | 222 | 31.1% | 11.2% |
| Failure to recalibrate | 219 | 30.7% | 11% |
| Intermittent communication failure | 209 | 29.3% | 10.7% |
| Failure to deliverthe device did not deliver the dose or item | 134 | 18.8% | 18.3% |
| Inaccurate delivery | 25 | 3.5% | 8.9% |
| Calibration problem | 22 | 3.1% | 3.4% |
| Loose or intermittent connection | 17 | 2.4% | 1.4% |
| Therapeutic or diagnostic output failure | 17 | 2.4% | 1.6% |
| Device sensing problem | 14 | 2% | 1.3% |
| Failure to calibrate | 12 | 1.7% | 2.6% |
| Gas/air leak | 12 | 1.7% | 2.4% |
| Device alarm system | 9 | 1.3% | 2.6% |
| Defective devicethe device was defective | 8 | 1.1% | 0.9% |
| Output problem | 8 | 1.1% | 0.4% |
| Communication or transmission problemthe device could not communicate or transmit | 6 | 0.8% | 0.3% |
| Excess flow or over-infusion | 6 | 0.8% | 2.4% |
| Breakthe device broke | 5 | 0.7% | 1.6% |
| Device displays incorrect message | 5 | 0.7% | 13.6% |
| Incorrect, inadequate or imprecise result or readings | 5 | 0.7% | 0.6% |
| Medical gas supply problem | 4 | 0.6% | 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 |
|---|---|---|
| Low oxygen saturation | 15 | 2.1% |
| Bradycardiaslow heart rate | 4 | 0.6% |
| Hypoxialow oxygen | 3 | 0.4% |
| Low blood pressure/ hypotension | 3 | 0.4% |
| Cardiac arrestthe heart stopped | 1 | 0.1% |
| Collapse | 1 | 0.1% |
| Facial paralysis | 1 | 0.1% |
| High pulmonary arterial wedge pressure | 1 | 0.1% |
| No patient involvement | 1 | 0.1% |
| Tachycardiafast heart rate | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | INOmax DSIR Plus (Delivery System) | Product code MRN | All MAUDE reports |
|---|---|---|---|
| Reports | 714 | 2,059 | 26,136,888 |
| Share of that pool | — | 34.7% | 0% |
| Classified as death, per 1,000 reports | 3 | 15 | 9 |
| Classified as injury | 1.4% | 6.8% | 36.2% |
| Classified as malfunction | 98.3% | 89.5% | 62.3% |
| Filed by the manufacturer | 99.4% | 92.2% | 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 MRN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| INOmax DSIR (Delivery System) | 803 | 7 | 0.7% |
| Inomax Ds Delivery System | 182 | 0 | 0.5% |
| Aestiva | 794 | 329 | 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 INOmax DSIR Plus (Delivery System) reports
How many FDA reports name INOmax DSIR Plus (Delivery System)?
714 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 53 in the latest 12 months.
What kinds of events are reported?
malfunction (98.3%), injury (1.4%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high readings (31.1%), failure to recalibrate (30.7%), intermittent communication failure (29.3%), failure to deliver (18.8%) and inaccurate delivery (3.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that INOmax DSIR Plus (Delivery System) 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.