Devices › Ventilator, continuous, facility use
Device brand name · Volume ventilator
Bear: medical device reports filed with FDA
600 reports name it, 1994–2011. Manufacturer given most often on reports: Bear Medical Systems. Product code CBK.
- 600
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 65.7%
- classified as malfunction
- 91.8% across the product code
- 2.3%
- classified as death, as reported
- 14 reports · not verified by FDA
FDA's MAUDE database holds 600 reports that name the brand "Bear" (volume ventilator), received between February 1994 and September 2011; the manufacturer given most often on reports is Bear Medical Systems. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and 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 malfunction (65.7%), injury (30.3%) and death (2.3%); 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 failure to cycle (41.2%), device inoperable (18.2%) and replace (15.7%). The patient problems coded most often are manual ventilation required, 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
No report naming Bear was received in the five years to August 2026; the latest was received in September 2011.
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 cycle | 247 | 41.2% | 3.6% |
| Device inoperablethe device could not be used | 109 | 18.2% | 4.3% |
| Replace | 94 | 15.7% | 1.2% |
| Device alarm system | 36 | 6% | 1.8% |
| Device issuea problem with the device | 35 | 5.8% | 0.4% |
| Other (for use when an appropriate device code cannot be identified) | 30 | 5% | 0.2% |
| Alarm, audible | 29 | 4.8% | 0.8% |
| Device displays incorrect message | 25 | 4.2% | 9% |
| Decrease in pressure | 23 | 3.8% | 0.8% |
| Increase in pressure | 22 | 3.7% | 0.4% |
| Loss of powerthe device lost power | 17 | 2.8% | 1.5% |
| Failure, intermittent | 13 | 2.2% | 0.1% |
| Pressure, insufficient | 12 | 2% | 0% |
| Erratic or intermittent display | 11 | 1.8% | 0.9% |
| Disconnection | 10 | 1.7% | 0.4% |
| Mechanical problema mechanical problem | 10 | 1.7% | 7.4% |
| Self-activation or keying | 9 | 1.5% | 0.5% |
| Air leak | 8 | 1.3% | 0.1% |
| Failure to deliverthe device did not deliver the dose or item | 8 | 1.3% | 1.2% |
| No audible alarm | 8 | 1.3% | 0.8% |
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 |
|---|---|---|
| Manual ventilation required | 61 | 10.2% |
| Low oxygen saturation | 20 | 3.3% |
| Deaththe patient died; cause not stated by this term | 13 | 2.2% |
| Respiratory distress syndrome of newborns | 12 | 2% |
| Therapy/non-surgical treatment, additional | 10 | 1.7% |
| Respiratory distressdifficulty breathing | 7 | 1.2% |
| Hypoxialow oxygen | 5 | 0.8% |
| Pneumothoraxa collapsed lung | 5 | 0.8% |
| Respiratory failurethe lungs could not supply enough oxygen | 5 | 0.8% |
| Therapy/non-surgical treatment/delayed/prolonged | 5 | 0.8% |
| Adult respiratory distress syndrome | 4 | 0.7% |
| Breathing difficulties | 4 | 0.7% |
| Chronic obstructive pulmonary disease (COPD) | 4 | 0.7% |
| Other (for use when an appropriate patient code cannot be identified) | 4 | 0.7% |
| Pneumonialung infection | 4 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bear | Product code CBK | All MAUDE reports |
|---|---|---|---|
| Reports | 600 | 213,387 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 23 | 11 | 9 |
| Classified as injury | 30.3% | 6.8% | 36.2% |
| Classified as malfunction | 65.7% | 91.8% | 62.3% |
| Filed by the manufacturer | 93.8% | 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 Bear reports
How many FDA reports name Bear?
600 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 (65.7%), injury (30.3%) and death (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to cycle (41.2%), device inoperable (18.2%), replace (15.7%), device alarm system (6%) and device issue (5.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (93.8%), distributor reports (1.7%) and voluntary reports (1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bear 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.