Devices › Ventilator, continuous, non-life-supporting
Device brand name · Ventilator continuous non-life-supporting
DreamStation BiPAP autoSV: medical device reports filed with FDA
2,725 reports name it, 2021–2026. Manufacturer given most often on reports: Respironics. Product code MNS.
- 2,725
- device reports naming the brand
- 0% of all MAUDE reports · about 537 a year
- 104
- reports, 12 months to August 2026
- 703 in the 12 months before
- 83%
- classified as malfunction
- 86% across the product code
- 1.5%
- classified as death, as reported
- 42 reports · not verified by FDA
2,725 medical device reports received by FDA name the brand "DreamStation BiPAP autoSV" (ventilator continuous non-life-supporting); the manufacturer given most often on reports is Respironics; received from June 2021 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
104 reports arrived in the 12 months to August 2026, down 85% from 703 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 (83%), injury (15.4%) and death (1.5%); across all ventilator, continuous, non-life-supporting reports (product code MNS) death is recorded in 3.4% and malfunction in 86%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are degraded (96.3%), contamination (4.4%) and corroded (1.8%). The patient problems coded most often are dyspnea, headache and dizziness. 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 11,458 reports carrying product code MNS. 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 |
|---|---|---|---|
| Degraded | 2,625 | 96.3% | 78.7% |
| Contamination | 119 | 4.4% | 3.4% |
| Corrodedthe device corroded | 48 | 1.8% | 2.1% |
| Circuit failure | 20 | 0.7% | 6.3% |
| Contamination /decontamination problem | 11 | 0.4% | 0.2% |
| Device emits odor | 8 | 0.3% | 0.2% |
| Electrical /electronic property probleman electrical or electronic problem | 5 | 0.2% | 9.9% |
| Material integrity problema problem with the device material | 5 | 0.2% | 0.2% |
| Noise, audible | 5 | 0.2% | 0.2% |
| Failure to power up | 4 | 0.1% | 0.5% |
| Fire | 4 | 0.1% | 0.1% |
| Activation problem | 3 | 0.1% | 0.1% |
| Excessive heating | 3 | 0.1% | 0.1% |
| Insufficient device problem information | 3 | 0.1% | 0.3% |
| Device contamination with chemical or other material | 2 | 0.1% | 0% |
| Overheating of device | 2 | 0.1% | 0.5% |
| Power problem | 2 | 0.1% | 0.2% |
| Unexpected shutdown | 2 | 0.1% | 0.6% |
| Complete loss of power | 1 | 0% | 0.1% |
| Component missing | 1 | 0% | 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 |
|---|---|---|
| Dyspneashortness of breath | 298 | 10.9% |
| Headachehead pain | 274 | 10.1% |
| Dizzinesslight-headedness or unsteadiness | 182 | 6.7% |
| Cancer | 151 | 5.5% |
| Coughcough | 114 | 4.2% |
| Sore throat | 113 | 4.1% |
| Respiratory tract infectiona respiratory infection | 95 | 3.5% |
| Asthmaasthma | 90 | 3.3% |
| Eye irritationeye irritation | 79 | 2.9% |
| Nauseafeeling sick | 63 | 2.3% |
| Inflammationinflammation | 58 | 2.1% |
| Skin inflammation/ irritation | 56 | 2.1% |
| Hypersensitivity/allergic reaction | 51 | 1.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 41 | 1.5% |
| Vomitingbeing sick | 37 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | DreamStation BiPAP autoSV | Product code MNS | All MAUDE reports |
|---|---|---|---|
| Reports | 2,725 | 11,458 | 26,136,888 |
| Share of that pool | — | 23.8% | 0% |
| Classified as death, per 1,000 reports | 15 | 34 | 9 |
| Classified as injury | 15.4% | 10.4% | 36.2% |
| Classified as malfunction | 83% | 86% | 62.3% |
| Filed by the manufacturer | 99.8% | 98.9% | 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 MNS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| BiPAP A30 | 1,847 | 1,565 | 0.2% |
| BiPAP autoSV ADV | 1,039 | 176 | 2.4% |
| DreamStation BiPAP ST30 | 682 | 26 | 1.3% |
| Bipap Focus Noninvasive Ventilator System | 382 | 0 | 1% |
| BiPAP AVAPS | 388 | 273 | 0.3% |
| BiPAP A30, Germany | 343 | 343 | 0% |
| BiPAP AVAPS C Series | 331 | 237 | 0.9% |
| Dreamstation Bipap St | 237 | 0 | 0.4% |
| DreamStation BiPAP AVAPS | 216 | 23 | 0.9% |
| Bipap S/T C Series | 230 | 96 | 3.5% |
| Dreamstation Bipap Avaps30 | 220 | 8 | 3.6% |
| BiPAP A30-S, Germany | 178 | 178 | 0% |
| BiPAP autoSV | 209 | 84 | 1.4% |
| Dreamstation Bipap | 337 | 4 | 1.5% |
| Respironics | 17,693 | 2,239 | 0.3% |
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." 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 DreamStation BiPAP autoSV reports
How many FDA reports name DreamStation BiPAP autoSV?
2,725 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 104 in the latest 12 months.
What kinds of events are reported?
malfunction (83%), injury (15.4%) and death (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
degraded (96.3%), contamination (4.4%), corroded (1.8%), circuit failure (0.7%) and contamination /decontamination problem (0.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that DreamStation BiPAP autoSV 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.