Device manufacturer, as written on reports
Respironics: medical device reports filed with FDA
388,198 reports name it as the manufacturer of the device involved, 1994–2026.
- 388,198
- reports naming it as manufacturer
- 1.5% of all MAUDE reports
- 73,768
- reports, 12 months to August 2026
- 85,162 in the 12 months before
- 84.5%
- classified as malfunction
- 62.3% across all reports
- 1.4%
- classified as death, as reported
- 0.9% across all reports
388,198 medical device reports received by FDA give Respironics as the manufacturer of the device involved, 1.5% of the MAUDE database, from January 1994 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
73,768 reports arrived in the 12 months to August 2026, down 13% from 85,162 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 (84.5%), injury (13.9%) and death (1.4%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."
Brands named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| DreamStation Auto CPAP | Ventilator, non-continuous (respirator) | 145,454 | 27,741 | 0.9% |
| Trilogy 100 | Ventilator, continuous, facility use | 30,005 | 2,056 | 0.9% |
| REMstar Auto A-Flex | Ventilator, non-continuous (respirator) | 19,545 | 7,083 | 1% |
| DreamStation Auto BiPAP | Ventilator, non-continuous (respirator) | 15,170 | 871 | 1.8% |
| REMstar Pro C-Flex+ | Ventilator, non-continuous (respirator) | 14,547 | 4,689 | 1.2% |
| DreamStation CPAP | Ventilator, non-continuous (respirator) | 13,754 | 336 | 2.5% |
| Philips CPAP Device | Ventilator, non-continuous (respirator) | 12,717 | 58 | 5.5% |
| Respironics | Sv70 ventilator | 11,348 | 2,239 | 0.3% |
| DreamStation CPAP Pro | Ventilator, non-continuous (respirator) | 10,710 | 674 | 0.8% |
| REMstar AutoA-Flex | Ventilator, non-continuous (respirator) | 8,578 | 1,732 | 1.1% |
| Trilogy Evo | Ventilator, continuous, facility use | 8,554 | 943 | 1.1% |
| REMstar Auto | Ventilator, non-continuous (respirator) | 5,053 | 1,424 | 0.9% |
| Trilogy 202 | Ventilator, continuous, facility use | 4,697 | 74 | 0.3% |
| BiPAP Auto BiFlex | Ventilator, non-continuous (respirator) | 4,444 | 1,327 | 1.4% |
| DreamStation | Ventilator, non-continuous (respirator) | 3,847 | 1,703 | 1.6% |
| Trilogy O2 | Ventilator, continuous, facility use | 3,781 | 48 | 0.3% |
| REMstar Plus C-Flex | Ventilator, non-continuous (respirator) | 3,655 | 1,582 | 0.8% |
| Dreamstation Auto | Ventilator, non-continuous (respirator) | 3,040 | 38 | 0.3% |
| DreamStation BiPAP Pro | Ventilator, non-continuous (respirator) | 2,929 | 108 | 1.9% |
| BiPAP A40 | Sv70 ventilator | 2,900 | 1,775 | 1% |
| DreamStation BiPAP autoSV | Ventilator, continuous, non-life-supporting | 2,667 | 104 | 1.5% |
| REMstar Plus | Ventilator, non-continuous (respirator) | 2,361 | 499 | 1.9% |
| DS2Adv Auto CPAP | Ventilator, non-continuous (respirator) | 2,360 | 443 | 4.4% |
| Philips CPAP | Ventilator, non-continuous (respirator) | 2,359 | 11 | 4.3% |
| DreamStation Expert | Ventilator, non-continuous (respirator) | 2,240 | 1,842 | 0% |
| Trilogy | Ventilator, continuous, facility use | 2,072 | 663 | 0.4% |
| BiPAP Pro BiFlex | Ventilator, non-continuous (respirator) | 2,037 | 631 | 1.6% |
| BiPAP A30 | Ventilator, continuous, non-life-supporting | 1,428 | 1,565 | 0.2% |
| Trilogy EV300, USA | Ventilator, continuous, facility use | 1,342 | 772 | 0% |
| REMstar System One 60 Series | Ventilator, non-continuous (respirator) | 1,332 | 880 | 2.2% |
Brands with a page on this site, 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."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| BZD | Ventilator, non-continuous (respirator) | 297,031 | 76.5% |
| CBK | Ventilator, continuous, facility use | 61,544 | 15.9% |
| MNT | Sv70 ventilator | 16,554 | 4.3% |
| MNS | Ventilator, continuous, non-life-supporting | 10,926 | 2.8% |
| CAW | Generator, oxygen, portable | 1,118 | 0.3% |
| BTI | Compressor, air, portable | 753 | 0.2% |
| BTT | Humidifier, respiratory gas, (direct patient interface) | 158 | 0% |
| CAF | Nebulizer (direct patient interface) | 95 | 0% |
| FLS | Monitor, apnea, facility use | 48 | 0% |
| BTM | Ventilator, emergency, manual (resuscitator) | 43 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Respironics reports
How many FDA device reports name Respironics as manufacturer?
388,198 reports through August 2026, 73,768 of them in the latest 12 months.
Which of its brands appear most often?
DreamStation Auto CPAP (145,454), Trilogy 100 (30,005), REMstar Auto A-Flex (19,545), DreamStation Auto BiPAP (15,170) and REMstar Pro C-Flex+ (14,547).
Which device types does it report on?
ventilator, non-continuous (respirator) (76.5%), ventilator, continuous, facility use (15.9%), sv70 ventilator (4.3%) and ventilator, continuous, non-life-supporting (2.8%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."
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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.