Heater, breathing system w/wo controller (not humidifier or nebulizer: medical device reports filed with FDA

3,558 reports carry this product code, 1992–2026; 12 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.

3,558
reports with this product code: 0% of all MAUDE reports; 221
reports, 12 months to August 2026: 186 in the 12 months before; 95.6%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code BZE is FDA's classification for "Heater, breathing system w/wo controller (not humidifier or nebulizer" (anesthesiology panel), a class 2 device. 3,558 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

221 reports arrived in the 12 months to August 2026, up 19% from 186 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 (95.6%), injury (3.1%) and other (0.5%). 12 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
Infant Dual Heated Evaqua2 Breathing Circuit	653	0	0%	98.6%
Adult Dual Heated Evaqua Breathing Circuit	472	0	0.2%	99.6%
Adult Dual Heated Evaqua2 Breathing Circuit	424	0	0.2%	98.1%
Fisher & Paykel Healthcare	351	3,374	0.3%	98.9%
Infant Dual-Heated Evaqua Breathing Circuit	237	0	0%	97.5%
Adult Dual-Heated Evaqua Breathing Circuit	151	0	0%	98.7%
Adult Breathing Circuit	25	0	0.7%	97.6%
Hudson Concha Neptune	23	0	0.1%	99.6%
Fisher and Paykel Healthcare	21	134	0%	99.7%
Adult Dual Heated Breathing Circuit	19	0	0%	98.7%
AirLife	3	37	2.6%	61.3%
Respiratory Humidifier	1	0	1.8%	88.2%

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
Fisher & Paykel Healthcare	2,728	76.7%
Carefusion	140	3.9%
Allegiance Healthcare	65	1.8%
Vyaire Medical	17	0.5%
Cardinal Health	14	0.4%
Teleflex	11	0.3%
Hamilton Medical	6	0.2%
Respironics	2	0.1%

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

Death0.3%11

Injury3.1%110

Malfunction95.6%3,400

Other0.5%18

Not given0.5%19

Who filed

Manufacturer report97.7%3,477

Voluntary report1.1%38

User facility report0%0

Distributor report0%0

Not given1.2%43

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

Device problems coded

Device problem (FDA code)	Reports	Share
Leak/splashthe device leaked	770	21.6%
Crackthe device cracked	541	15.2%
Gas/air leak	374	10.5%
Device operates differently than expectedthe device behaved unexpectedly	269	7.6%
Hole in material	201	5.6%
Breakthe device broke	188	5.3%
Insufficient heating	183	5.1%
Disconnection	163	4.6%
Air leak	139	3.9%
Melted	126	3.5%
Fluid/blood leak	124	3.5%
Temperature problem	106	3%
Connection problema connection problem	96	2.7%
Device displays incorrect message	59	1.7%
Moisture or humidity problem	59	1.7%
Failure of device to self-test	49	1.4%
Material split, cut or torn	44	1.2%
Device issuea problem with the device	42	1.2%
Loose or intermittent connection	42	1.2%
Therapeutic or diagnostic output failure	42	1.2%

Questions about heater, breathing system w/wo controller (not humidifier or nebulizer reports

What is product code BZE?

FDA's classification code for "Heater, breathing system w/wo controller (not humidifier or nebulizer", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,558 reports through August 2026, 221 of them in the latest 12 months.

Which brands appear most often?

Infant Dual Heated Evaqua2 Breathing Circuit (653), Adult Dual Heated Evaqua Breathing Circuit (472), Adult Dual Heated Evaqua2 Breathing Circuit (424), Fisher & Paykel Healthcare (351) and Infant Dual-Heated Evaqua Breathing Circuit (237). 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.