Devices › Ventilator, non-continuous (respirator)
Device brand name · Ventilator non-continuous respirator
REMstar System One 60 Series: medical device reports filed with FDA
1,560 reports name it, 2024–2026. Manufacturer given most often on reports: Respironics. Product code BZD.
- 1,560
- device reports naming the brand
- 0% of all MAUDE reports · about 816 a year
- 880
- reports, 12 months to August 2026
- 676 in the 12 months before
- 95.9%
- classified as malfunction
- 80.7% across the product code
- 2.2%
- classified as death, as reported
- 34 reports · not verified by FDA
FDA's MAUDE database holds 1,560 reports that name the brand "REMstar System One 60 Series" (ventilator non-continuous respirator), received between August 2024 and August 2026; the manufacturer given most often on reports is Respironics. Spellings of one product vary from report to report.
880 reports arrived in the 12 months to August 2026, up 30% from 676 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 (95.9%), death (2.2%) and injury (1.9%); across all ventilator, non-continuous (respirator) reports (product code BZD) death is recorded in 1.5% and malfunction in 80.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are degraded (95.1%), thermal decomposition of device (1.1%) and overheating of device (0.8%). The patient problems coded most often are cancer, cough and dyspnea. 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 303,240 reports carrying product code BZD. 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 | 1,483 | 95.1% | 95.4% |
| Thermal decomposition of device | 17 | 1.1% | 0.2% |
| Overheating of device | 13 | 0.8% | 0.7% |
| Excessive heating | 7 | 0.4% | 0.1% |
| Material integrity problema problem with the device material | 4 | 0.3% | 0.2% |
| Smoking | 3 | 0.2% | 0.1% |
| Contamination | 2 | 0.1% | 4.4% |
| Environmental particulates | 2 | 0.1% | 0% |
| Fire | 2 | 0.1% | 0.1% |
| Temperature problem | 2 | 0.1% | 0.1% |
| Corrodedthe device corroded | 1 | 0.1% | 0.8% |
| Device contaminated during manufacture or shipping | 1 | 0.1% | 0% |
| Electrical /electronic property probleman electrical or electronic problem | 1 | 0.1% | 0.1% |
| Failure to power up | 1 | 0.1% | 0.1% |
| Material discolored | 1 | 0.1% | 0% |
| Material separation | 1 | 0.1% | 0% |
| Sparking | 1 | 0.1% | 0% |
| Unexpected shutdown | 1 | 0.1% | 0% |
| Unraveled material | 1 | 0.1% | 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 |
|---|---|---|
| Cancer | 16 | 1% |
| Coughcough | 10 | 0.6% |
| Dyspneashortness of breath | 10 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 0.3% |
| Dizzinesslight-headedness or unsteadiness | 4 | 0.3% |
| Headachehead pain | 4 | 0.3% |
| Asthmaasthma | 3 | 0.2% |
| Chronic obstructive pulmonary disease (COPD) | 3 | 0.2% |
| Fatiguetiredness | 2 | 0.1% |
| Inflammationinflammation | 2 | 0.1% |
| Nasal congestiona blocked nose | 2 | 0.1% |
| Pulmonary dysfunction | 2 | 0.1% |
| Pulmonary emphysema | 2 | 0.1% |
| Anxietyanxiety | 1 | 0.1% |
| Bronchitischest infection | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | REMstar System One 60 Series | Product code BZD | All MAUDE reports |
|---|---|---|---|
| Reports | 1,560 | 303,240 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 22 | 15 | 9 |
| Classified as injury | 1.9% | 17.7% | 36.2% |
| Classified as malfunction | 95.9% | 80.7% | 62.3% |
| Filed by the manufacturer | 100% | 99% | 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 BZD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| DreamStation Auto CPAP | 146,780 | 27,741 | 0.9% |
| REMstar Auto A-Flex | 19,656 | 7,083 | 1% |
| DreamStation Auto BiPAP | 15,316 | 871 | 1.8% |
| REMstar Pro C-Flex+ | 14,643 | 4,689 | 1.2% |
| DreamStation CPAP | 13,895 | 336 | 2.5% |
| Philips CPAP Device | 12,779 | 58 | 5.5% |
| DreamStation CPAP Pro | 10,789 | 674 | 0.8% |
| REMstar AutoA-Flex | 8,659 | 1,732 | 1.1% |
| REMstar Auto | 5,089 | 1,424 | 0.9% |
| BiPAP Auto BiFlex | 4,487 | 1,327 | 1.4% |
| DreamStation | 4,210 | 1,703 | 1.6% |
| REMstar Plus C-Flex | 3,682 | 1,582 | 0.8% |
| Dreamstation Auto | 3,150 | 38 | 0.3% |
| DreamStation BiPAP Pro | 3,049 | 108 | 1.9% |
| REMstar Plus | 2,581 | 499 | 1.9% |
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 REMstar System One 60 Series reports
How many FDA reports name REMstar System One 60 Series?
1,560 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 880 in the latest 12 months.
What kinds of events are reported?
malfunction (95.9%), death (2.2%) and injury (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
degraded (95.1%), thermal decomposition of device (1.1%), overheating of device (0.8%), excessive heating (0.4%) and material integrity problem (0.3%). 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 REMstar System One 60 Series 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.