Devices › Ventilator, continuous, facility use
Device brand name · Ventilators intensive care
Evita 4: medical device reports filed with FDA
255 reports name it, 1998–2026. Product code CBK.
- 255
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 16
- reports, 12 months to August 2026
- 12 in the 12 months before
- 78.8%
- classified as malfunction
- 91.8% across the product code
- 9%
- classified as death, as reported
- 23 reports · not verified by FDA
FDA's MAUDE database holds 255 reports that name the brand "Evita 4" (ventilators intensive care), received between July 1998 and August 2026. Spellings of one product vary from report to report.
16 reports arrived in the 12 months to August 2026, up 33% from 12 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 (78.8%), death (9%) and injury (8.2%); 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 failure to deliver (16.5%), gas output problem (11.4%) and loss of power (8.2%). The patient problems coded most often are death, low oxygen saturation and manual ventilation required. 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 |
|---|---|---|---|
| Failure to deliverthe device did not deliver the dose or item | 42 | 16.5% | 1.2% |
| Gas output problem | 29 | 11.4% | 0.7% |
| Loss of powerthe device lost power | 21 | 8.2% | 1.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 16 | 6.3% | 5.5% |
| Decrease in pressure | 14 | 5.5% | 0.8% |
| Device displays incorrect message | 13 | 5.1% | 9% |
| Complete loss of power | 12 | 4.7% | 0.4% |
| Device alarm system | 12 | 4.7% | 1.8% |
| Unexpected shutdown | 12 | 4.7% | 1.1% |
| Material erosion | 11 | 4.3% | 0% |
| No display/image | 10 | 3.9% | 5.2% |
| Computer operating system problem | 9 | 3.5% | 0.2% |
| Noise, audible | 9 | 3.5% | 0.4% |
| Inappropriate or unexpected reset | 8 | 3.1% | 0.2% |
| No pressure | 7 | 2.7% | 0.1% |
| Device inoperablethe device could not be used | 5 | 2% | 4.3% |
| Insufficient device problem information | 5 | 2% | 1.2% |
| Replace | 5 | 2% | 1.2% |
| Reset problem | 5 | 2% | 0.2% |
| Gas/air leak | 4 | 1.6% | 1.4% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 4 | 1.6% |
| Low oxygen saturation | 4 | 1.6% |
| Manual ventilation required | 3 | 1.2% |
| Cardiac arrestthe heart stopped | 2 | 0.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.4% |
| Bradycardiaslow heart rate | 1 | 0.4% |
| Cut(s) | 1 | 0.4% |
| Hypoventilation | 1 | 0.4% |
| Injurya physical injury | 1 | 0.4% |
| No patient involvement | 1 | 0.4% |
| Oversedation | 1 | 0.4% |
| Respiratory arrestbreathing stopped | 1 | 0.4% |
| Therapeutic effects, unexpected | 1 | 0.4% |
| Urinary retentionbeing unable to empty the bladder | 1 | 0.4% |
| Ventilator dependent | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Evita 4 | Product code CBK | All MAUDE reports |
|---|---|---|---|
| Reports | 255 | 213,387 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 90 | 11 | 9 |
| Classified as injury | 8.2% | 6.8% | 36.2% |
| Classified as malfunction | 78.8% | 91.8% | 62.3% |
| Filed by the manufacturer | 95.3% | 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% |
| Vela Ventilator | 8,446 | 0 | 0.3% |
| 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% |
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 Evita 4 reports
How many FDA reports name Evita 4?
255 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 16 in the latest 12 months.
What kinds of events are reported?
malfunction (78.8%), death (9%) and injury (8.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to deliver (16.5%), gas output problem (11.4%), loss of power (8.2%), device operates differently than expected (6.3%) and decrease in pressure (5.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.3%), voluntary reports (0.4%) and distributor reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Evita 4 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.