Device brand name · Ventilator continuous minimal ventilatory support facility use
Respironics: medical device reports filed with FDA
17,693 reports name it, 1999–2026. Manufacturer given most often on reports: Respironics. Product code MNT.
- 17,693
- device reports naming the brand
- 0.1% of all MAUDE reports · about 644 a year
- 2,239
- reports, 12 months to August 2026
- 2,907 in the 12 months before
- 98.7%
- classified as malfunction
- 98.3% across the product code
- 0.3%
- classified as death, as reported
- 47 reports · not verified by FDA
17,693 medical device reports received by FDA name the brand "Respironics" (ventilator continuous minimal ventilatory support facility use); the manufacturer given most often on reports is Respironics; received from January 1999 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
2,239 reports arrived in the 12 months to August 2026, down 23% from 2,907 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 (98.7%), injury (1%) and death (0.3%); 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 inadequate user interface (21.9%), device sensing problem (8.2%) and device alarm system (5.9%). The patient problems coded most often are hypoxia, dyspnea and low oxygen saturation. 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 |
|---|---|---|---|
| Inadequate user interface | 3,868 | 21.9% | 9% |
| Device sensing problem | 1,455 | 8.2% | 3.4% |
| Device alarm system | 1,044 | 5.9% | 4.7% |
| Failure to sense | 848 | 4.8% | 2% |
| Battery problema problem with the battery | 722 | 4.1% | 3.7% |
| Unexpected shutdown | 688 | 3.9% | 2.3% |
| Power problem | 663 | 3.7% | 2.1% |
| Gas/air leak | 612 | 3.5% | 1.5% |
| Mechanical problema mechanical problem | 578 | 3.3% | 1.6% |
| Excessive heating | 541 | 3.1% | 1.2% |
| Failure to power up | 510 | 2.9% | 3.5% |
| Complete loss of power | 492 | 2.8% | 1.1% |
| Failure to run on battery | 457 | 2.6% | 1% |
| No display/image | 443 | 2.5% | 2.7% |
| Tidal volume fluctuations | 370 | 2.1% | 1% |
| Failure to deliverthe device did not deliver the dose or item | 352 | 2% | 0.8% |
| Display difficult to read | 306 | 1.7% | 0.7% |
| Unstable | 297 | 1.7% | 0.6% |
| Defective alarm | 290 | 1.6% | 1.3% |
| Unintended power up | 236 | 1.3% | 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 |
|---|---|---|
| Hypoxialow oxygen | 102 | 0.6% |
| Dyspneashortness of breath | 33 | 0.2% |
| Low oxygen saturation | 23 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 9 | 0.1% |
| Cardiac arrestthe heart stopped | 8 | 0% |
| Respiratory arrestbreathing stopped | 7 | 0% |
| No patient involvement | 4 | 0% |
| Abnormal blood gases | 3 | 0% |
| Bradycardiaslow heart rate | 3 | 0% |
| Respiratory failurethe lungs could not supply enough oxygen | 3 | 0% |
| Angina | 2 | 0% |
| Discomfortdiscomfort | 2 | 0% |
| Impaired healingslow healing | 2 | 0% |
| Lethargysluggishness | 2 | 0% |
| Respiratory insufficiency | 2 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Respironics | Product code MNT | All MAUDE reports |
|---|---|---|---|
| Reports | 17,693 | 48,296 | 26,136,888 |
| Share of that pool | — | 36.6% | 0.1% |
| Classified as death, per 1,000 reports | 3 | 5 | 9 |
| Classified as injury | 1% | 1.1% | 36.2% |
| Classified as malfunction | 98.7% | 98.3% | 62.3% |
| Filed by the manufacturer | 99.7% | 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% |
| BiPAP A40 | 2,979 | 1,775 | 1% |
| 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 Respironics reports
How many FDA reports name Respironics?
17,693 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2,239 in the latest 12 months.
What kinds of events are reported?
malfunction (98.7%), injury (1%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
inadequate user interface (21.9%), device sensing problem (8.2%), device alarm system (5.9%), failure to sense (4.8%) and battery problem (4.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) 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 Respironics 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.