Devices › Heater, breathing system w/wo controller (not humidifier or nebulizer
Device brand name · Bze
Infant Dual Heated Evaqua2 Breathing Circuit: medical device reports filed with FDA
655 reports name it, 2011–2024. Manufacturer given most often on reports: Fisher & Paykel Healthcare. Product code BZE.
- 655
- device reports naming the brand
- 0% of all MAUDE reports · about 44 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.6%
- classified as malfunction
- 95.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 655 reports that name the brand "Infant Dual Heated Evaqua2 Breathing Circuit" (bze), received between September 2011 and May 2024; 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 (98.6%) and injury (1.4%); 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 crack (37.7%), leak/splash (21.2%) and disconnection (13%). The patient problems coded most often are no patient involvement, low oxygen saturation and bradycardia. 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 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 |
|---|---|---|---|
| Crackthe device cracked | 247 | 37.7% | 15.2% |
| Leak/splashthe device leaked | 139 | 21.2% | 21.6% |
| Disconnection | 85 | 13% | 4.6% |
| Gas/air leak | 57 | 8.7% | 10.5% |
| Breakthe device broke | 31 | 4.7% | 5.3% |
| Connection problema connection problem | 29 | 4.4% | 2.7% |
| Therapeutic or diagnostic output failure | 19 | 2.9% | 1.2% |
| Device issuea problem with the device | 18 | 2.7% | 1.2% |
| Loose or intermittent connection | 16 | 2.4% | 1.2% |
| Incorrect, inadequate or imprecise result or readings | 15 | 2.3% | 0.6% |
| Detachment of device or device componentpart of the device came off | 14 | 2.1% | 0.6% |
| Failure of device to self-test | 13 | 2% | 1.4% |
| Moisture or humidity problem | 12 | 1.8% | 1.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 1.5% | 7.6% |
| Material separation | 9 | 1.4% | 0.5% |
| Device displays incorrect message | 8 | 1.2% | 1.7% |
| Hole in material | 8 | 1.2% | 5.6% |
| Detachment of device component | 7 | 1.1% | 1% |
| Air leak | 6 | 0.9% | 3.9% |
| Device slipped | 6 | 0.9% | 0.3% |
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 | 158 | 24.1% |
| Low oxygen saturation | 15 | 2.3% |
| Bradycardiaslow heart rate | 5 | 0.8% |
| Tachycardiafast heart rate | 3 | 0.5% |
| Aspiration/inhalation | 1 | 0.2% |
| Burn(s)a burn | 1 | 0.2% |
| Cardiac arrestthe heart stopped | 1 | 0.2% |
| Erythemaskin redness | 1 | 0.2% |
| Fever | 1 | 0.2% |
| Full thickness (third degree) burn | 1 | 0.2% |
| Hypoventilation | 1 | 0.2% |
| Hypoxialow oxygen | 1 | 0.2% |
| Increased respiratory rate | 1 | 0.2% |
| Irritabilityirritability | 1 | 0.2% |
| Respiratory distressdifficulty breathing | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Infant Dual Heated Evaqua2 Breathing Circuit | Product code BZE | All MAUDE reports |
|---|---|---|---|
| Reports | 655 | 3,558 | 26,136,888 |
| Share of that pool | — | 18.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 1.4% | 3.1% | 36.2% |
| Classified as malfunction | 98.6% | 95.6% | 62.3% |
| Filed by the manufacturer | 99.8% | 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 |
|---|---|---|---|
| Adult Dual Heated Evaqua Breathing Circuit | 478 | 0 | 0.2% |
| 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 Infant Dual Heated Evaqua2 Breathing Circuit reports
How many FDA reports name Infant Dual Heated Evaqua2 Breathing Circuit?
655 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 (98.6%) and injury (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
crack (37.7%), leak/splash (21.2%), disconnection (13%), gas/air leak (8.7%) and break (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Infant Dual Heated Evaqua2 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.