Ventilator, continuous, facility use: medical device reports filed with FDA

213,387 reports carry this product code, 1991–2026; 30 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

213,387
reports with this product code: 0.8% of all MAUDE reports; 14,394
reports, 12 months to August 2026: 16,268 in the 12 months before; 91.8%
classified as malfunction: 62.3% across all reports; 1.1%
classified as death, as reported: 0.9% across all reports

Product code CBK is FDA's classification for "Ventilator, continuous, facility use" (anesthesiology panel), a class 2 device. 213,387 medical device reports carry this product code, 0.8% of the MAUDE database, from December 1991 to August 2026.

14,394 reports arrived in the 12 months to August 2026, down 12% from 16,268 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 (91.8%), injury (6.8%) and death (1.1%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Trilogy 100	31,013	2,056	0.9%	97.2%
840 Ventilator	18,190	27	0.4%	82.7%
Hamilton Medical Ag	10,324	0	0.3%	98.9%
Trilogy Evo	8,571	943	1.1%	97.4%
Vela Ventilator	8,445	0	0.3%	81.2%
Servo-I	6,383	3	1.3%	95%
Esprit Ventilator	6,014	0	0.4%	98.2%
Vocsn	5,305	854	0.4%	96.3%
Trilogy 202	5,217	74	0.3%	99.2%
Carescape R860	4,937	50	0.2%	99.2%
Carescape	4,870	2,289	0.1%	99.4%
980 Ventilator	4,648	117	0.2%	80.3%
Trilogy O2	4,290	48	0.3%	98.9%
Avea Ventilator	3,941	0	0.5%	79.3%
V200 Ventilator	3,476	0	0.2%	99.1%
Uni-Vent Model 731	3,296	0	0.3%	99.6%
Servo-S	3,231	0	0.7%	97.7%
Engstrom	3,170	304	0.2%	99.3%
Bellavista	2,720	412	0.5%	76.7%
Pulmonetic	2,575	0	2.9%	93%
Astral 150 - AMER	2,417	272	0.8%	98.4%
Trilogy	2,098	663	0.4%	88.2%
Servo-i Base Unit	1,921	607	0.6%	97.8%
Servo-U	1,873	1	1.2%	90.2%
Trilogy 200	1,675	138	0.9%	98.6%
Ht70 Ventilator	1,654	13	0.6%	62.3%
Servo-s Base Unit	1,569	477	0.4%	98.3%
Ltv 1200 Ventilator	1,552	12	7.8%	66%
Carefusion	1,491	0	1.1%	89.6%
Ltv	1,484	28	3.5%	82.2%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Respironics	61,544	28.8%
Maquet Critical Care	18,082	8.5%
Hamilton Medical	16,410	7.7%
Datex-Ohmeda	13,512	6.3%
Covidien	13,104	6.1%
Vyaire Medical	12,518	5.9%
Resmed	10,609	5%
Respironics California	10,192	4.8%
Carefusion	7,186	3.4%
Ventec Life Systems	5,405	2.5%
Zoll Medical	4,228	2%
Newport Medical Instruments	3,982	1.9%
Nellcor Puritan Bennett	2,942	1.4%
Covidien Formerly Nellcor	2,772	1.3%
Puritan Bennett	2,263	1.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1.1%2,259

Injury6.8%14,404

Malfunction91.8%195,831

Other0.2%436

Not given0.2%457

Who filed

Manufacturer report95.9%204,674

Voluntary report0.8%1,663

User facility report0%0

Distributor report2.1%4,439

Not given1.2%2,611

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device displays incorrect message	19,238	9%
Mechanical problema mechanical problem	15,868	7.4%
Output problem	12,889	6%
Device operates differently than expectedthe device behaved unexpectedly	11,824	5.5%
No display/image	11,033	5.2%
Battery problema problem with the battery	9,702	4.5%
Circuit failure	9,684	4.5%
Device inoperablethe device could not be used	9,082	4.3%
Electrical /electronic property probleman electrical or electronic problem	8,183	3.8%
Failure to cycle	7,633	3.6%
Failure to calibrate	7,146	3.3%
Failure to recalibrate	6,124	2.9%
Failure to power up	6,109	2.9%
Failure to run on battery	5,516	2.6%
Failure to charge	5,383	2.5%
Failure of device to self-test	4,603	2.2%
Defective component	4,390	2.1%
Device alarm system	3,776	1.8%
Insufficient flow or under infusion	3,719	1.7%
Display or visual feedback problem	3,308	1.6%

Questions about ventilator, continuous, facility use reports

What is product code CBK?

FDA's classification code for "Ventilator, continuous, facility use", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

213,387 reports through August 2026, 14,394 of them in the latest 12 months.

Which brands appear most often?

Trilogy 100 (31,013), 840 Ventilator (18,190), Hamilton Medical Ag (10,324), Trilogy Evo (8,571) and Vela Ventilator (8,445). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.