Nebulizer (direct patient interface): medical device reports filed with FDA

3,131 reports carry this product code, 1992–2026; 11 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.

3,131
reports with this product code: 0% of all MAUDE reports; 573
reports, 12 months to August 2026: 160 in the 12 months before; 85.1%
classified as malfunction: 62.3% across all reports; 1.4%
classified as death, as reported: 0.9% across all reports

Product code CAF is FDA's classification for "Nebulizer (direct patient interface)" (anesthesiology panel), a class 2 device. 3,131 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

573 reports arrived in the 12 months to August 2026, up 258% from 160 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 (85.1%), injury (8.4%) and other (3.4%). 11 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
Hudson Micro Mist Nebulizer W/Elong	255	0	0%	100%
Hudson Nebulizer Adaptor 033 Sterile Japanese	173	0	0%	100%
Hudson RCI	50	121	1.3%	84.4%
AirLife	8	37	2.6%	61.3%
Devilbiss	3	9	3.9%	90.8%
Envoy Aer Compressor 230v Aus 9153632953	3	0	0%	98.7%
Drive	2	20	4.4%	13.1%
Vicks	2	5	0.5%	20.8%
50psi Compressor Mobilaire 9153619938	1	0	0%	99.6%
Softheat	1	0	0.4%	1.6%
Ventilator	1	3	7.5%	33.3%

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
Teleflex Medical	1,158	37%
Respironics	95	3%
Teleflex	91	2.9%
Vyaire Medical	27	0.9%
Philips Respironics	23	0.7%
Fisher & Paykel Healthcare	19	0.6%
Invacare Suzhou	10	0.3%
Invacare	7	0.2%
Ok Biotech	4	0.1%
Philips / Respironics	3	0.1%
Allegiance Healthcare	1	0%
Baxter Healthcare	1	0%
Covidien Formerly Nellcor	1	0%
Covidien Formerly Nellcor Puritan	1	0%
Invacare Rehabilitation Equip	1	0%

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

Death1.4%43

Injury8.4%264

Malfunction85.1%2,666

Other3.4%106

Not given1.7%52

Who filed

Manufacturer report76%2,378

Voluntary report20.2%631

User facility report0%0

Distributor report1.1%34

Not given2.8%88

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	418	13.4%
Leak/splashthe device leaked	217	6.9%
Connection problema connection problem	171	5.5%
Infusion or flow problema problem with flow or infusion	164	5.2%
Breakthe device broke	154	4.9%
Device operates differently than expectedthe device behaved unexpectedly	123	3.9%
No flow	116	3.7%
Disconnection	82	2.6%
Fitting problem	66	2.1%
Smoking	61	1.9%
Fluid/blood leak	59	1.9%
Inaccurate delivery	55	1.8%
Defective devicethe device was defective	54	1.7%
Overheating of device	52	1.7%
Tear, rip or hole in device packaging	51	1.6%
Fire	46	1.5%
Improper flow or infusion	45	1.4%
Device emits odor	41	1.3%
Melted	41	1.3%
Restricted flow rate	41	1.3%

Questions about nebulizer (direct patient interface) reports

What is product code CAF?

FDA's classification code for "Nebulizer (direct patient interface)", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,131 reports through August 2026, 573 of them in the latest 12 months.

Which brands appear most often?

Hudson Micro Mist Nebulizer W/Elong (255), Hudson Nebulizer Adaptor 033 Sterile Japanese (173), Hudson RCI (50), AirLife (8) and Devilbiss (3). 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.