Devices › Ventilator, continuous, facility use
Device brand name · Ventilator continuous facility use
Engstrom: medical device reports filed with FDA
3,183 reports name it, 2012–2026. Manufacturer given most often on reports: Datex-Ohmeda. Product code CBK.
- 3,183
- device reports naming the brand
- 0% of all MAUDE reports · about 225 a year
- 304
- reports, 12 months to August 2026
- 418 in the 12 months before
- 99.3%
- classified as malfunction
- 91.8% across the product code
- 0.2%
- classified as death, as reported
- 6 reports · not verified by FDA
3,183 medical device reports received by FDA name the brand "Engstrom" (ventilator continuous facility use); the manufacturer given most often on reports is Datex-Ohmeda; received from May 2012 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
304 reports arrived in the 12 months to August 2026, down 27% from 418 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 (99.3%), injury (0.5%) and death (0.2%); 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 no display/image (36.1%), failure to run on battery (24.5%) and insufficient flow or under infusion (17.2%). 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 |
|---|---|---|---|
| No display/image | 1,148 | 36.1% | 5.2% |
| Failure to run on battery | 781 | 24.5% | 2.6% |
| Insufficient flow or under infusion | 546 | 17.2% | 1.7% |
| Therapeutic or diagnostic output failure | 112 | 3.5% | 0.4% |
| Mechanical problema mechanical problem | 110 | 3.5% | 7.4% |
| Electrical /electronic property probleman electrical or electronic problem | 69 | 2.2% | 3.8% |
| Power problem | 57 | 1.8% | 1.4% |
| Failure to power up | 48 | 1.5% | 2.9% |
| Unexpected therapeutic results | 45 | 1.4% | 0.1% |
| No visual prompts/feedback | 36 | 1.1% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 28 | 0.9% | 5.5% |
| Improper flow or infusion | 27 | 0.8% | 1.3% |
| Detachment of device or device componentpart of the device came off | 26 | 0.8% | 0.1% |
| Unexpected shutdown | 23 | 0.7% | 1.1% |
| Battery problema problem with the battery | 18 | 0.6% | 4.5% |
| Breakthe device broke | 16 | 0.5% | 0.6% |
| Display or visual feedback problem | 11 | 0.3% | 1.6% |
| Infusion or flow problema problem with flow or infusion | 10 | 0.3% | 0.9% |
| Computer software problema software problem | 7 | 0.2% | 0.4% |
| Device tipped over | 7 | 0.2% | 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 |
|---|---|---|
| No patient involvement | 68 | 2.1% |
| Low oxygen saturation | 7 | 0.2% |
| Deaththe patient died; cause not stated by this term | 3 | 0.1% |
| Cardiac arrestthe heart stopped | 2 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0% |
| Bradycardiaslow heart rate | 1 | 0% |
| Capsular contracturescar tissue tightening around an implant | 1 | 0% |
| Contusiona bruise | 1 | 0% |
| Cyanosis | 1 | 0% |
| Dementiadementia | 1 | 0% |
| Injurya physical injury | 1 | 0% |
| Pulmonary embolisma blood clot in the lung | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Engstrom | Product code CBK | All MAUDE reports |
|---|---|---|---|
| Reports | 3,183 | 213,387 | 26,136,888 |
| Share of that pool | — | 1.5% | 0% |
| Classified as death, per 1,000 reports | 2 | 11 | 9 |
| Classified as injury | 0.5% | 6.8% | 36.2% |
| Classified as malfunction | 99.3% | 91.8% | 62.3% |
| Filed by the manufacturer | 99.8% | 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 Engstrom reports
How many FDA reports name Engstrom?
3,183 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 304 in the latest 12 months.
What kinds of events are reported?
malfunction (99.3%), injury (0.5%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no display/image (36.1%), failure to run on battery (24.5%), insufficient flow or under infusion (17.2%), therapeutic or diagnostic output failure (3.5%) and mechanical problem (3.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Engstrom 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.