Devices › Continuous, ventilator, home use
Device brand name · Continuous ventilator
Breas Vivo 50: medical device reports filed with FDA
165 reports name it, 2015–2022. Manufacturer given most often on reports: Breas Medical. Product code NOU.
- 165
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 92.1%
- classified as malfunction
- 95.7% across the product code
- 5.5%
- classified as death, as reported
- 9 reports · not verified by FDA
FDA's MAUDE database holds 165 reports that name the brand "Breas Vivo 50" (continuous ventilator), received between March 2015 and July 2022; the manufacturer given most often on reports is Breas Medical. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (92.1%), death (5.5%) and injury (1.2%); 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 device displays incorrect message (43.6%), device operates differently than expected (15.2%) and battery problem (7.9%). The patient problems coded most often are cardiac arrest, coma and death. 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 |
|---|---|---|---|
| Device displays incorrect message | 72 | 43.6% | 14.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 25 | 15.2% | 0.6% |
| Battery problema problem with the battery | 13 | 7.9% | 11.7% |
| Unexpected shutdown | 8 | 4.8% | 1.8% |
| Failure to run on ac/dc | 7 | 4.2% | 0.1% |
| Device alarm system | 5 | 3% | 1.2% |
| Power problem | 5 | 3% | 6.1% |
| Device inoperablethe device could not be used | 3 | 1.8% | 1.6% |
| Failure to run on battery | 3 | 1.8% | 0.1% |
| Therapeutic or diagnostic output failure | 3 | 1.8% | 0.6% |
| Defective devicethe device was defective | 2 | 1.2% | 0.1% |
| Device stops intermittentlythe device stopped now and then | 2 | 1.2% | 1.1% |
| Electrical /electronic property probleman electrical or electronic problem | 2 | 1.2% | 2.4% |
| Increase in pressure | 2 | 1.2% | 0% |
| Insufficient cooling | 2 | 1.2% | 0% |
| No flow | 2 | 1.2% | 0.1% |
| Volume accuracy problem | 2 | 1.2% | 0% |
| Burst container or vessel | 1 | 0.6% | 0% |
| Calibration error | 1 | 0.6% | 0% |
| Crackthe device cracked | 1 | 0.6% | 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 |
|---|---|---|
| Cardiac arrestthe heart stopped | 2 | 1.2% |
| Coma | 2 | 1.2% |
| Deaththe patient died; cause not stated by this term | 2 | 1.2% |
| Respiratory insufficiency | 2 | 1.2% |
| Loss of consciousnesspassing out | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Breas Vivo 50 | Product code NOU | All MAUDE reports |
|---|---|---|---|
| Reports | 165 | 7,010 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 55 | 14 | 9 |
| Classified as injury | 1.2% | 2.8% | 36.2% |
| Classified as malfunction | 92.1% | 95.7% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| 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 Breas Vivo 50 reports
How many FDA reports name Breas Vivo 50?
165 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 (92.1%), death (5.5%) and injury (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (43.6%), device operates differently than expected (15.2%), battery problem (7.9%), unexpected shutdown (4.8%) and failure to run on ac/dc (4.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Breas Vivo 50 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.