Devices › Continuous, ventilator, home use
Device brand name · Ventilator continuous facility/home
Astral 150 - DEU: medical device reports filed with FDA
1,501 reports name it, 2014–2026. Manufacturer given most often on reports: Resmed. Product code NOU.
- 1,501
- device reports naming the brand
- 0% of all MAUDE reports · about 128 a year
- 76
- reports, 12 months to August 2026
- 93 in the 12 months before
- 99.5%
- classified as malfunction
- 95.7% across the product code
- 0.1%
- classified as death, as reported
- 2 reports · not verified by FDA
1,501 medical device reports received by FDA name the brand "Astral 150 - DEU" (ventilator continuous facility/home); the manufacturer given most often on reports is Resmed; received from October 2014 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
76 reports arrived in the 12 months to August 2026, down 18% from 93 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 (99.5%), injury (0.3%) and death (0.1%); 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 (25.6%), device displays incorrect message (21.9%) and protective measures problem (21.5%). The patient problems coded most often are no patient involvement, dyspnea and respiratory distress. 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 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 | 385 | 25.6% | 15.2% |
| Device displays incorrect message | 329 | 21.9% | 14.8% |
| Protective measures problem | 323 | 21.5% | 33.3% |
| Battery problema problem with the battery | 135 | 9% | 11.7% |
| Power problem | 104 | 6.9% | 6.1% |
| Inadequate user interface | 71 | 4.7% | 5.6% |
| Failure to charge | 56 | 3.7% | 2.8% |
| Inappropriate or unexpected reset | 55 | 3.7% | 2.1% |
| Failure to power up | 50 | 3.3% | 3% |
| Failure of device to self-test | 38 | 2.5% | 2.1% |
| Device stops intermittentlythe device stopped now and then | 35 | 2.3% | 1.1% |
| No display/image | 32 | 2.1% | 1.8% |
| Unexpected shutdown | 32 | 2.1% | 1.8% |
| Display or visual feedback problem | 25 | 1.7% | 0.4% |
| Charging problem | 24 | 1.6% | 2.7% |
| Complete loss of power | 20 | 1.3% | 2% |
| Device inoperablethe device could not be used | 20 | 1.3% | 1.6% |
| Device alarm system | 18 | 1.2% | 1.2% |
| Electrical /electronic property probleman electrical or electronic problem | 18 | 1.2% | 2.4% |
| Pressure problem | 13 | 0.9% | 0.5% |
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 | 81 | 5.4% |
| Dyspneashortness of breath | 6 | 0.4% |
| Respiratory distressdifficulty breathing | 5 | 0.3% |
| Low oxygen saturation | 3 | 0.2% |
| Deaththe patient died; cause not stated by this term | 2 | 0.1% |
| Apnea | 1 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.1% |
| Corneal abrasion | 1 | 0.1% |
| Cyanosis | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Astral 150 - DEU | Product code NOU | All MAUDE reports |
|---|---|---|---|
| Reports | 1,501 | 7,010 | 26,136,888 |
| Share of that pool | — | 21.4% | 0% |
| Classified as death, per 1,000 reports | 1 | 14 | 9 |
| Classified as injury | 0.3% | 2.8% | 36.2% |
| Classified as malfunction | 99.5% | 95.7% | 62.3% |
| Filed by the manufacturer | 72.3% | 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 - 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 100 Sc - Deu | 250 | 0 | 0% |
| 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 150 - DEU reports
How many FDA reports name Astral 150 - DEU?
1,501 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 76 in the latest 12 months.
What kinds of events are reported?
malfunction (99.5%), injury (0.3%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to calibrate (25.6%), device displays incorrect message (21.9%), protective measures problem (21.5%), battery problem (9%) and power problem (6.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (72.3%) and distributor reports (27.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Astral 150 - 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.