Devices › Heater, breathing system w/wo controller (not humidifier or nebulizer
Device brand name · Bze
Adult Dual Heated Evaqua Breathing Circuit: medical device reports filed with FDA
478 reports name it, 2009–2015. Manufacturer given most often on reports: Fisher & Paykel Healthcare. Product code BZE.
- 478
- device reports naming the brand
- 0% of all MAUDE reports · about 27 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.6%
- classified as malfunction
- 95.6% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 478 reports that name the brand "Adult Dual Heated Evaqua Breathing Circuit" (bze), received between February 2009 and December 2015; the manufacturer given most often on reports is Fisher & Paykel Healthcare. 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 (99.6%), death (0.2%) and other (0.2%); across all heater, breathing system w/wo controller (not humidifier or nebulizer reports (product code BZE) death is recorded in 0.3% and malfunction in 95.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are leak/splash (26.2%), device operates differently than expected (24.7%) and hole in material (18.4%). The patient problems coded most often are no patient involvement, injury and cardiac arrest. 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 Adult Dual Heated Evaqua Breathing Circuit was received in the five years to August 2026; the latest was received in December 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,558 reports carrying product code BZE. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 125 | 26.2% | 21.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 118 | 24.7% | 7.6% |
| Hole in material | 88 | 18.4% | 5.6% |
| Breakthe device broke | 52 | 10.9% | 5.3% |
| Air leak | 32 | 6.7% | 3.9% |
| Device displays incorrect message | 18 | 3.8% | 1.7% |
| Failure of device to self-test | 17 | 3.6% | 1.4% |
| Fluid/blood leak | 16 | 3.3% | 3.5% |
| Device alarm system | 15 | 3.1% | 0.8% |
| Connection problema connection problem | 9 | 1.9% | 2.7% |
| Device damaged prior to usethe device was damaged before use | 7 | 1.5% | 0.5% |
| Bent | 5 | 1% | 0.8% |
| Temperature problem | 4 | 0.8% | 3% |
| Gas/air leak | 3 | 0.6% | 10.5% |
| Insufficient heating | 3 | 0.6% | 5.1% |
| Material perforation | 3 | 0.6% | 0.2% |
| Mechanical problema mechanical problem | 3 | 0.6% | 0.5% |
| Misconnection | 3 | 0.6% | 0.2% |
| Out-of-box failure | 3 | 0.6% | 0.1% |
| Circuit failure | 2 | 0.4% | 0.5% |
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 | 231 | 48.3% |
| Injurya physical injury | 2 | 0.4% |
| Cardiac arrestthe heart stopped | 1 | 0.2% |
| Low blood pressure/ hypotension | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Adult Dual Heated Evaqua Breathing Circuit | Product code BZE | All MAUDE reports |
|---|---|---|---|
| Reports | 478 | 3,558 | 26,136,888 |
| Share of that pool | — | 13.4% | 0% |
| Classified as death, per 1,000 reports | 2 | 3 | 9 |
| Classified as injury | 0% | 3.1% | 36.2% |
| Classified as malfunction | 99.6% | 95.6% | 62.3% |
| Filed by the manufacturer | 100% | 97.7% | 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 BZE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Infant Dual Heated Evaqua2 Breathing Circuit | 655 | 0 | 0% |
| Adult Dual Heated Evaqua2 Breathing Circuit | 424 | 0 | 0.2% |
| Fisher & Paykel Healthcare | 4,780 | 3,374 | 0.3% |
| Infant Dual-Heated Evaqua Breathing Circuit | 237 | 0 | 0% |
| Adult Dual-Heated Evaqua Breathing Circuit | 151 | 0 | 0% |
| Adult Breathing Circuit | 292 | 0 | 0.7% |
| Hudson Concha Neptune | 1,679 | 0 | 0.1% |
| Fisher and Paykel Healthcare | 333 | 134 | 0% |
| Adult Dual Heated Breathing Circuit | 232 | 0 | 0% |
| AirLife | 155 | 37 | 2.6% |
| Respiratory Humidifier | 448 | 0 | 1.8% |
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 Adult Dual Heated Evaqua Breathing Circuit reports
How many FDA reports name Adult Dual Heated Evaqua Breathing Circuit?
478 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 (99.6%), death (0.2%) and other (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (26.2%), device operates differently than expected (24.7%), hole in material (18.4%), break (10.9%) and air leak (6.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Adult Dual Heated Evaqua Breathing Circuit 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.