Apparatus, nitric oxide delivery: medical device reports filed with FDA

2,059 reports carry this product code, 1998–2026; 4 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,059
reports with this product code: 0% of all MAUDE reports; 175
reports, 12 months to August 2026: 128 in the 12 months before; 89.5%
classified as malfunction: 62.3% across all reports; 1.5%
classified as death, as reported: 0.9% across all reports

Product code MRN is FDA's classification for "Apparatus, nitric oxide delivery" (anesthesiology panel), a class 2 device. 2,059 medical device reports carry this product code, 0% of the MAUDE database, from June 1998 to August 2026.

175 reports arrived in the 12 months to August 2026, up 37% from 128 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 (89.5%), injury (6.8%) and death (1.5%). 4 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
INOmax DSIR (Delivery System)	778	7	0.7%	91.3%
INOmax DSIR Plus (Delivery System)	714	53	0.3%	98.3%
Inomax Ds Delivery System	172	0	0.5%	87.4%
Aestiva	1	329	0.1%	98.2%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Mallinckrodt Manufacturing	1,251	60.8%
Datex-Ohmeda	41	2%
Ge Healthcare	3	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1.5%31

Injury6.8%139

Malfunction89.5%1,842

Other1.1%22

Not given1.2%25

Who filed

Manufacturer report92.2%1,898

Voluntary report2.4%49

User facility report0%0

Distributor report1.3%26

Not given4.2%86

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Failure to deliverthe device did not deliver the dose or item	377	18.3%
Device displays incorrect message	280	13.6%
High readingsreadings were too high	230	11.2%
Failure to recalibrate	227	11%
Intermittent communication failure	220	10.7%
Inaccurate delivery	184	8.9%
Device operates differently than expectedthe device behaved unexpectedly	124	6%
No display/image	76	3.7%
Calibration problem	70	3.4%
Gas output problem	61	3%
Device alarm system	54	2.6%
Failure to calibrate	54	2.6%
Excess flow or over-infusion	50	2.4%
Gas/air leak	49	2.4%
Device inoperablethe device could not be used	38	1.8%
Breakthe device broke	33	1.6%
Therapeutic or diagnostic output failure	32	1.6%
Loose or intermittent connection	28	1.4%
Nonstandard device	27	1.3%
Device sensing problem	26	1.3%

Questions about apparatus, nitric oxide delivery reports

What is product code MRN?

FDA's classification code for "Apparatus, nitric oxide delivery", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,059 reports through August 2026, 175 of them in the latest 12 months.

Which brands appear most often?

INOmax DSIR (Delivery System) (778), INOmax DSIR Plus (Delivery System) (714), Inomax Ds Delivery System (172) and Aestiva (1). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.