Devices › Continuous, ventilator, home use

Device brand name · Ventilator continuous facility/home

Astral 100 Sc - Deu: medical device reports filed with FDA

250 reports name it, 2014–2025. Manufacturer given most often on reports: Resmed. Product code NOU.

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.

250
device reports naming the brand: 0% of all MAUDE reports · about 22 a year; 0
reports, 12 months to August 2026: 14 in the 12 months before; 100%
classified as malfunction: 95.7% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

250 medical device reports received by FDA name the brand "Astral 100 Sc - Deu" (ventilator continuous facility/home); the manufacturer given most often on reports is Resmed; received from December 2014 to May 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, against 14 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 (100%); across all continuous, ventilator, home use reports (product code NOU) death is recorded in 1.4% and malfunction in 95.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to calibrate (33.6%), device displays incorrect message (23.6%) and power problem (10.8%). The patient problems coded most often are 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

Death0%0

Injury0%0

Malfunction100%250

Other0%0

Not given0%0

Who filed the report

Manufacturer report80.4%201

Voluntary report0%0

User facility report0%0

Distributor report19.6%49

Not given0%0

Grey bar: all 7,010 reports carrying product code NOU. 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
Failure to calibrate	84	33.6%	15.2%
Device displays incorrect message	59	23.6%	14.8%
Power problem	27	10.8%	6.1%
Inappropriate or unexpected reset	16	6.4%	2.1%
Battery problema problem with the battery	12	4.8%	11.7%
Device inoperablethe device could not be used	10	4%	1.6%
Device stops intermittentlythe device stopped now and then	10	4%	1.1%
Charging problem	7	2.8%	2.7%
No display/image	6	2.4%	1.8%
Failure of device to self-test	4	1.6%	2.1%
Communication or transmission problemthe device could not communicate or transmit	2	0.8%	0.1%
Electrical /electronic property probleman electrical or electronic problem	2	0.8%	2.4%
Failure to charge	2	0.8%	2.8%
Failure to power up	2	0.8%	3%
Protective measures problem	2	0.8%	33.3%
Unexpected shutdown	2	0.8%	1.8%
Device operates differently than expectedthe device behaved unexpectedly	1	0.4%	0.6%
Material deformation	1	0.4%	0%

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
No patient involvement	34	13.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Astral 100 Sc - Deu	Product code NOU	All MAUDE reports
Reports	250	7,010	26,136,888
Share of that pool	—	3.6%	0%
Classified as death, per 1,000 reports	0	14	9
Classified as injury	0%	2.8%	36.2%
Classified as malfunction	100%	95.7%	62.3%
Filed by the manufacturer	80.4%	62.9%	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 NOU

Brand	Reports	Latest 12 months	Classified as death
Astral 150 - AMER	3,919	272	0.8%
Astral 150 - DEU	1,501	76	0.1%
Astral 150 - Fukuda	1,792	84	0.2%
Astral 150 Dbl Kit Fra	1,895	12	1.1%
Astral 100 - AMER	1,082	92	1%
Astral 150 -EUR4	769	92	0.4%
Astral 100 - APAC2	593	38	0.3%
Astral 100 Deu	374	6	0%
Astral 150 - Apac2	605	18	0%
Breas Vivo 50	165	0	5.5%
Astral 150 - Eur2	398	22	0.5%
Astral 100 - Eur1	481	8	0%
Astral 150 - EUR1	201	18	0%
Astral Battery Pack	492	0	0%
Astral 100 - EUR4	204	6	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." 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 Astral 100 Sc - Deu reports

How many FDA reports name Astral 100 Sc - Deu?

250 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to calibrate (33.6%), device displays incorrect message (23.6%), power problem (10.8%), inappropriate or unexpected reset (6.4%) and battery problem (4.8%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (80.4%) and distributor reports (19.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Astral 100 Sc - Deu 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.