Devices › Ventilator, continuous, facility use
Device brand name · Ventilator continuous facility use
Vela Ventilator: medical device reports filed with FDA
8,446 reports name it, 2014–2024. Manufacturer given most often on reports: Vyaire Medical. Product code CBK.
- 8,446
- device reports naming the brand
- 0% of all MAUDE reports · about 681 a year
- 0
- reports, 12 months to August 2026
- 5 in the 12 months before
- 81.2%
- classified as malfunction
- 91.8% across the product code
- 0.3%
- classified as death, as reported
- 22 reports · not verified by FDA
8,446 medical device reports received by FDA name the brand "Vela Ventilator" (ventilator continuous facility use); the manufacturer given most often on reports is Vyaire Medical; received from February 2014 to October 2024. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 5 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 (81.2%), injury (18.5%) and death (0.3%); across all ventilator, continuous, facility use reports (product code CBK) death is recorded in 1.1% and malfunction in 91.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are mechanical problem (43%), device operates differently than expected (28.3%) and device displays incorrect message (26.3%). The patient problems coded most often are no patient involvement, low oxygen saturation and death. 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 213,387 reports carrying product code CBK. 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 |
|---|---|---|---|
| Mechanical problema mechanical problem | 3,628 | 43% | 7.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 2,394 | 28.3% | 5.5% |
| Device displays incorrect message | 2,220 | 26.3% | 9% |
| Device inoperablethe device could not be used | 338 | 4% | 4.3% |
| Calibration problem | 324 | 3.8% | 0.7% |
| No display/image | 232 | 2.7% | 5.2% |
| Display or visual feedback problem | 165 | 2% | 1.6% |
| Output problem | 144 | 1.7% | 6% |
| Image display error/artifact | 96 | 1.1% | 0.3% |
| Failure to calibrate | 69 | 0.8% | 3.3% |
| Leak/splashthe device leaked | 68 | 0.8% | 0.9% |
| Volume accuracy problem | 55 | 0.7% | 0.2% |
| Failure to cycle | 34 | 0.4% | 3.6% |
| Defective component | 30 | 0.4% | 2.1% |
| Device stops intermittentlythe device stopped now and then | 29 | 0.3% | 0.7% |
| Improper device output | 29 | 0.3% | 0.1% |
| Erratic or intermittent display | 27 | 0.3% | 0.9% |
| Tactile prompts/feedback | 26 | 0.3% | 0% |
| Failure to conduct | 23 | 0.3% | 0.1% |
| Inaccurate delivery | 22 | 0.3% | 0.4% |
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 |
|---|---|---|
| No patient involvement | 4,040 | 47.8% |
| Low oxygen saturation | 21 | 0.2% |
| Deaththe patient died; cause not stated by this term | 14 | 0.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 0.1% |
| Cardiac arrestthe heart stopped | 4 | 0% |
| Stacking breaths | 4 | 0% |
| Respiratory distressdifficulty breathing | 3 | 0% |
| Cardiopulmonary arrest | 2 | 0% |
| Hypoventilation | 2 | 0% |
| Apnea | 1 | 0% |
| Bone cement implantation syndrome | 1 | 0% |
| Cyanosis | 1 | 0% |
| Dyspneashortness of breath | 1 | 0% |
| Hemorrhage/blood loss/bleeding | 1 | 0% |
| Hypoxialow oxygen | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Vela Ventilator | Product code CBK | All MAUDE reports |
|---|---|---|---|
| Reports | 8,446 | 213,387 | 26,136,888 |
| Share of that pool | — | 4% | 0% |
| Classified as death, per 1,000 reports | 3 | 11 | 9 |
| Classified as injury | 18.5% | 6.8% | 36.2% |
| Classified as malfunction | 81.2% | 91.8% | 62.3% |
| Filed by the manufacturer | 99.9% | 95.9% | 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 CBK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Trilogy 100 | 31,022 | 2,056 | 0.9% |
| 840 Ventilator | 18,191 | 27 | 0.4% |
| Hamilton Medical Ag | 10,331 | 0 | 0.3% |
| Trilogy Evo | 8,583 | 943 | 1.1% |
| Servo-I | 6,390 | 3 | 1.3% |
| Esprit Ventilator | 6,015 | 0 | 0.4% |
| Vocsn | 5,308 | 854 | 0.4% |
| Trilogy 202 | 5,217 | 74 | 0.3% |
| Carescape R860 | 4,968 | 50 | 0.2% |
| Carescape | 4,902 | 2,289 | 0.1% |
| 980 Ventilator | 4,651 | 117 | 0.2% |
| Trilogy O2 | 4,290 | 48 | 0.3% |
| Avea Ventilator | 3,943 | 0 | 0.5% |
| V200 Ventilator | 3,476 | 0 | 0.2% |
| Uni-Vent Model 731 | 3,305 | 0 | 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 Vela Ventilator reports
How many FDA reports name Vela Ventilator?
8,446 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (81.2%), injury (18.5%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanical problem (43%), device operates differently than expected (28.3%), device displays incorrect message (26.3%), device inoperable (4%) and calibration problem (3.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Vela Ventilator 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.