Devices › Ventilator, continuous, facility use
Device brand name · Ventilator
Ventilator: medical device reports filed with FDA
174 reports name it, 1993–2026. Manufacturer given most often on reports: Puritan-Bennett. Product code CBK.
- 174
- device reports naming the brand
- 0% of all MAUDE reports · about 5 a year
- 3
- reports, 12 months to August 2026
- 0 in the 12 months before
- 33.3%
- classified as malfunction
- 91.8% across the product code
- 7.5%
- classified as death, as reported
- 13 reports · not verified by FDA
FDA's MAUDE database holds 174 reports that name the brand "Ventilator" (ventilator), received between January 1993 and June 2026; the manufacturer given most often on reports is Puritan-Bennett. Spellings of one product vary from report to report.
3 reports arrived in the 12 months to August 2026, with none 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 injury (46%), malfunction (33.3%) and death (7.5%); 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 device output (14.4%), mechanical problem (7.5%) and false device output (5.7%). The patient problems coded most often are respiratory distress, hypoventilation 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 device output | 25 | 14.4% | 0.3% |
| Mechanical problema mechanical problem | 13 | 7.5% | 7.4% |
| False device output | 10 | 5.7% | 0% |
| Device alarm system | 9 | 5.2% | 1.8% |
| Failure to cycle | 7 | 4% | 3.6% |
| Electrical /electronic property probleman electrical or electronic problem | 6 | 3.4% | 3.8% |
| Output, high | 5 | 2.9% | 0% |
| Device maintenance issue | 4 | 2.3% | 0.3% |
| Leak/splashthe device leaked | 4 | 2.3% | 0.9% |
| Lockout mechanism failure | 4 | 2.3% | 0% |
| Alarm, failure of warning | 3 | 1.7% | 0.1% |
| Increase in pressure | 3 | 1.7% | 0.4% |
| Material separation | 3 | 1.7% | 0.1% |
| Battery charger, defective | 2 | 1.1% | 0% |
| Defective component | 2 | 1.1% | 2.1% |
| Design/structure problem | 2 | 1.1% | 0% |
| Detachment of device component | 2 | 1.1% | 0.1% |
| Device emits odor | 2 | 1.1% | 0.2% |
| Device inoperablethe device could not be used | 2 | 1.1% | 4.3% |
| Device issuea problem with the device | 2 | 1.1% | 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 |
|---|---|---|
| Respiratory distressdifficulty breathing | 10 | 5.7% |
| Hypoventilation | 8 | 4.6% |
| Deaththe patient died; cause not stated by this term | 7 | 4% |
| Cardiopulmonary arrest | 6 | 3.4% |
| Cyanosis | 4 | 2.3% |
| Airflow, restricted | 2 | 1.1% |
| Bradycardiaslow heart rate | 2 | 1.1% |
| Breathing difficulties | 2 | 1.1% |
| Hypoxialow oxygen | 2 | 1.1% |
| Low blood pressure/ hypotension | 2 | 1.1% |
| Other (for use when an appropriate patient code cannot be identified) | 2 | 1.1% |
| Adult respiratory distress syndrome | 1 | 0.6% |
| Anoxia | 1 | 0.6% |
| Dyspneashortness of breath | 1 | 0.6% |
| Low oxygen saturation | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ventilator | Product code CBK | All MAUDE reports |
|---|---|---|---|
| Reports | 174 | 213,387 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 75 | 11 | 9 |
| Classified as injury | 46% | 6.8% | 36.2% |
| Classified as malfunction | 33.3% | 91.8% | 62.3% |
| Filed by the manufacturer | 1.7% | 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 Ventilator reports
How many FDA reports name Ventilator?
174 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.
What kinds of events are reported?
injury (46%), malfunction (33.3%) and death (7.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no device output (14.4%), mechanical problem (7.5%), false device output (5.7%), device alarm system (5.2%) and failure to cycle (4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (52.3%), manufacturer reports (1.7%) and distributor reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that 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.