Continuous, ventilator, home use: medical device reports filed with FDA

7,010 reports carry this product code, 2006–2026; 29 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.

7,010
reports with this product code: 0% of all MAUDE reports; 978
reports, 12 months to August 2026: 852 in the 12 months before; 95.7%
classified as malfunction: 62.3% across all reports; 1.4%
classified as death, as reported: 0.9% across all reports

Product code NOU is FDA's classification for "Continuous, ventilator, home use" (anesthesiology panel), a class 2 device. 7,010 medical device reports carry this product code, 0% of the MAUDE database, from June 2006 to August 2026.

978 reports arrived in the 12 months to August 2026, up 15% from 852 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 (95.7%), injury (2.8%) and death (1.4%). 29 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
Astral 150 - AMER	1,500	272	0.8%	98.4%
Astral 150 - DEU	755	76	0.1%	99.5%
Astral 150 - Fukuda	660	84	0.2%	98%
Astral 150 Dbl Kit Fra	651	12	1.1%	98.6%
Astral 100 - AMER	376	92	1%	98.2%
Astral 150 -EUR4	308	92	0.4%	99.1%
Astral 100 - APAC2	277	38	0.3%	99.3%
Astral 100 Deu	188	6	0%	99.5%
Astral 150 - Apac2	179	18	0%	100%
Breas Vivo 50	155	0	5.5%	92.1%
Astral 100 Sc - Deu	144	0	0%	100%
Astral 150 - Eur2	138	22	0.5%	99%
Astral 100 - Eur1	100	8	0%	100%
Astral 150 - EUR1	99	18	0%	100%
Astral Battery Pack	92	0	0%	99.8%
Astral 100 - EUR4	89	6	2%	97.5%
Astral 150 - Apac	81	6	0%	99%
Astral 150 Dbl Kit - Eur4	65	2	0%	99.6%
Astral 150 - EUR3	63	10	0%	100%
Astral 100 - Apac	58	2	0%	100%
Astral 150 - APAC1	48	16	0%	100%
Ht70 Ventilator	36	13	0.6%	62.3%
Ht70 Plus Ventilator	26	0	0.7%	78.3%
Trilogy Evo	6	943	1.1%	97.4%
Ht50 Ventilator	2	0	1%	51%
Trilogy 100	2	2,056	0.9%	97.2%
Trilogy 100 Ventilator	2	185	2%	86%
Vocsn	2	854	0.4%	96.3%
Trilogy	1	663	0.4%	88.2%

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
Resmed	6,630	94.6%
Newport Medical Instruments	62	0.9%
Welch Allyn	60	0.9%
Philips / Respironics	8	0.1%
Respironics	7	0.1%
Ventec Life Systems	5	0.1%
Philips Respironics	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%98

Injury2.8%195

Malfunction95.7%6,708

Other0%2

Not given0.1%7

Who filed

Manufacturer report62.9%4,407

Voluntary report1.2%85

User facility report0%0

Distributor report35.8%2,513

Not given0.1%5

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

Device problems coded

Device problem (FDA code)	Reports	Share
Protective measures problem	2,336	33.3%
Failure to calibrate	1,069	15.2%
Device displays incorrect message	1,040	14.8%
Battery problema problem with the battery	820	11.7%
Power problem	427	6.1%
Inadequate user interface	396	5.6%
Failure to power up	208	3%
Failure to charge	198	2.8%
Charging problem	190	2.7%
Electrical /electronic property probleman electrical or electronic problem	170	2.4%
Failure of device to self-test	150	2.1%
Inappropriate or unexpected reset	148	2.1%
Complete loss of power	143	2%
No display/image	127	1.8%
Unexpected shutdown	124	1.8%
Device inoperablethe device could not be used	114	1.6%
Inappropriate tactile prompt/feedback	87	1.2%
Device alarm system	82	1.2%
Device stops intermittentlythe device stopped now and then	80	1.1%
Therapeutic or diagnostic output failure	45	0.6%

Questions about continuous, ventilator, home use reports

What is product code NOU?

FDA's classification code for "Continuous, ventilator, home use", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

7,010 reports through August 2026, 978 of them in the latest 12 months.

Which brands appear most often?

Astral 150 - AMER (1,500), Astral 150 - DEU (755), Astral 150 - Fukuda (660), Astral 150 Dbl Kit Fra (651) and Astral 100 - AMER (376). 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.