Device brand name · Ventilator continuous minimal ventilatory support facility use
BiPAP A40: medical device reports filed with FDA
2,979 reports name it, 2015–2026. Manufacturer given most often on reports: Respironics. Product code MNT.
- 2,979
- device reports naming the brand
- 0% of all MAUDE reports · about 259 a year
- 1,775
- reports, 12 months to August 2026
- 859 in the 12 months before
- 98.4%
- classified as malfunction
- 98.3% across the product code
- 1%
- classified as death, as reported
- 29 reports · not verified by FDA
FDA's MAUDE database holds 2,979 reports that name the brand "BiPAP A40" (ventilator continuous minimal ventilatory support facility use), received between January 2015 and August 2026; the manufacturer given most often on reports is Respironics. Spellings of one product vary from report to report.
1,775 reports arrived in the 12 months to August 2026, up 107% from 859 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 (98.4%), death (1%) and injury (0.7%); across all sv70 ventilator reports (product code MNT) death is recorded in 0.5% and malfunction in 98.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are electrical /electronic property problem (56.8%), circuit failure (37.9%) and degraded (28.7%). The patient problems coded most often are headache, anxiety and appropriate clinical signs, symptoms and conditions term/code not available. 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 48,296 reports carrying product code MNT. 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 |
|---|---|---|---|
| Electrical /electronic property probleman electrical or electronic problem | 1,691 | 56.8% | 6.6% |
| Circuit failure | 1,130 | 37.9% | 3.7% |
| Degraded | 856 | 28.7% | 1.9% |
| Unexpected shutdown | 113 | 3.8% | 2.3% |
| Device sensing problem | 26 | 0.9% | 3.4% |
| Computer software problema software problem | 21 | 0.7% | 0.3% |
| Thermal decomposition of device | 14 | 0.5% | 0.1% |
| Failure to power up | 11 | 0.4% | 3.5% |
| Mechanical problema mechanical problem | 10 | 0.3% | 1.6% |
| Power problem | 8 | 0.3% | 2.1% |
| Communication or transmission problemthe device could not communicate or transmit | 7 | 0.2% | 0.5% |
| Pressure problem | 4 | 0.1% | 0.9% |
| Contamination | 3 | 0.1% | 0.1% |
| Excess flow or over-infusion | 3 | 0.1% | 0.1% |
| Failure to calibrate | 3 | 0.1% | 0.8% |
| Operating system version or upgrade problem | 3 | 0.1% | 0% |
| Battery problema problem with the battery | 2 | 0.1% | 3.7% |
| Display or visual feedback problem | 2 | 0.1% | 1.3% |
| Electromagnetic compatibility problem | 2 | 0.1% | 0% |
| Insufficient device problem information | 2 | 0.1% | 0.3% |
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 |
|---|---|---|
| Headachehead pain | 2 | 0.1% |
| Anxietyanxiety | 1 | 0% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0% |
| Cancer | 1 | 0% |
| Chronic obstructive pulmonary disease (COPD) | 1 | 0% |
| Congenital defect/deformity | 1 | 0% |
| Coughcough | 1 | 0% |
| Dyspneashortness of breath | 1 | 0% |
| Hypoventilation | 1 | 0% |
| Hypoxialow oxygen | 1 | 0% |
| Inflammationinflammation | 1 | 0% |
| Low oxygen saturation | 1 | 0% |
| Nodule | 1 | 0% |
| Pneumothoraxa collapsed lung | 1 | 0% |
| Respiratory insufficiency | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | BiPAP A40 | Product code MNT | All MAUDE reports |
|---|---|---|---|
| Reports | 2,979 | 48,296 | 26,136,888 |
| Share of that pool | — | 6.2% | 0% |
| Classified as death, per 1,000 reports | 10 | 5 | 9 |
| Classified as injury | 0.7% | 1.1% | 36.2% |
| Classified as malfunction | 98.4% | 98.3% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 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 MNT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| V60 Ventilator | 24,912 | 0 | 0.3% |
| Respironics | 17,693 | 2,239 | 0.3% |
| BiPAP A40 Pro | 1,050 | 344 | 0.5% |
| V60 V60Plus Ventilator | 363 | 117 | 0% |
| Bipap A40 System Silver | 242 | 0 | 0.8% |
| BiPAP A40 System Silver, JP | 179 | 141 | 0.6% |
| BiPAP A30 | 1,847 | 1,565 | 0.2% |
| BiPAP A30, Germany | 343 | 343 | 0% |
| Nihon Kohden NKV-550 Series Ventilator System | 277 | 64 | 0% |
| Ventilator | 174 | 3 | 7.5% |
| Ventilator Continuous Facility Use | 385 | 0 | 3.6% |
| ARCHITECT Syphilis TP | 153 | 22 | 0% |
| BiPAP A30-S, Germany | 178 | 178 | 0% |
| Breas Vivo 50 | 165 | 0 | 5.5% |
| DreamStation Auto CPAP | 146,780 | 27,741 | 0.9% |
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 BiPAP A40 reports
How many FDA reports name BiPAP A40?
2,979 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,775 in the latest 12 months.
What kinds of events are reported?
malfunction (98.4%), death (1%) and injury (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
electrical /electronic property problem (56.8%), circuit failure (37.9%), degraded (28.7%), unexpected shutdown (3.8%) and device sensing problem (0.9%). 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 BiPAP A40 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.