Devices › Humidifier, respiratory gas, (direct patient interface)
Device brand name · Airvo 2 humidifier
Airvo 2 Humidifier: medical device reports filed with FDA
1,970 reports name it, 2017–2024. Manufacturer given most often on reports: Fisher & Paykel Healthcare. Product code BTT.
- 1,970
- device reports naming the brand
- 0% of all MAUDE reports · about 221 a year
- 0
- reports, 12 months to August 2026
- 2 in the 12 months before
- 98.1%
- classified as malfunction
- 96.1% across the product code
- 0.6%
- classified as death, as reported
- 12 reports · not verified by FDA
1,970 medical device reports received by FDA name the brand "Airvo 2 Humidifier" (airvo 2 humidifier); the manufacturer given most often on reports is Fisher & Paykel Healthcare; received from August 2017 to November 2024. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 2 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 (98.1%), injury (1.3%) and death (0.6%); across all humidifier, respiratory gas, (direct patient interface) reports (product code BTT) death is recorded in 0.7% and malfunction in 96.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are no audible alarm (95.3%), defective alarm (2.5%) and device alarm system (1.1%). The patient problems coded most often are no patient involvement, 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
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 18,530 reports carrying product code BTT. 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 |
|---|---|---|---|
| No audible alarm | 1,877 | 95.3% | 25.2% |
| Defective alarm | 50 | 2.5% | 15.7% |
| Device alarm system | 22 | 1.1% | 1.9% |
| No audible prompt/feedback | 13 | 0.7% | 0.1% |
| Defective component | 10 | 0.5% | 0.4% |
| Sparking | 6 | 0.3% | 0.1% |
| Defective devicethe device was defective | 5 | 0.3% | 0.3% |
| Insufficient device problem information | 5 | 0.3% | 0.5% |
| Therapeutic or diagnostic output failure | 5 | 0.3% | 0.2% |
| Loss of powerthe device lost power | 4 | 0.2% | 0.3% |
| Output problem | 4 | 0.2% | 0.1% |
| Protective measures problem | 4 | 0.2% | 0.1% |
| Unexpected shutdown | 4 | 0.2% | 0.4% |
| Device displays incorrect message | 3 | 0.2% | 0.9% |
| Inaudible or unclear audible prompt/feedback | 3 | 0.2% | 0% |
| Infusion or flow problema problem with flow or infusion | 3 | 0.2% | 0.2% |
| Breakthe device broke | 2 | 0.1% | 4.3% |
| Complete loss of power | 2 | 0.1% | 0.4% |
| Obstruction of flow | 2 | 0.1% | 0.2% |
| Power problem | 2 | 0.1% | 1.6% |
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 | 454 | 23% |
| Low oxygen saturation | 34 | 1.7% |
| Deaththe patient died; cause not stated by this term | 4 | 0.2% |
| Respiratory distressdifficulty breathing | 2 | 0.1% |
| Viral infectiona viral infection | 2 | 0.1% |
| Bacterial infectiona bacterial infection | 1 | 0.1% |
| Bradycardiaslow heart rate | 1 | 0.1% |
| Burn(s)a burn | 1 | 0.1% |
| Burning sensationa burning feeling | 1 | 0.1% |
| Cardiac arrestthe heart stopped | 1 | 0.1% |
| Discomfortdiscomfort | 1 | 0.1% |
| Pneumonialung infection | 1 | 0.1% |
| Respiratory arrestbreathing stopped | 1 | 0.1% |
| Virus | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Airvo 2 Humidifier | Product code BTT | All MAUDE reports |
|---|---|---|---|
| Reports | 1,970 | 18,530 | 26,136,888 |
| Share of that pool | — | 10.6% | 0% |
| Classified as death, per 1,000 reports | 6 | 7 | 9 |
| Classified as injury | 1.3% | 2.2% | 36.2% |
| Classified as malfunction | 98.1% | 96.1% | 62.3% |
| Filed by the manufacturer | 99.7% | 97% | 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 BTT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Fisher & Paykel Healthcare | 4,780 | 3,374 | 0.3% |
| Airvo2 Humidifier | 1,797 | 0 | 0.7% |
| Hudson Concha Neptune | 1,679 | 0 | 0.1% |
| Vented Autofeed Humidification Chamber | 809 | 0 | 0% |
| Vented Humidification Chamber | 493 | 0 | 0% |
| Vented Autofeed Chamber | 478 | 0 | 0% |
| Adult Inspiratory Heated Breathing Circuit | 449 | 0 | 0.2% |
| Respiratory Humidifier | 448 | 0 | 1.8% |
| Optiflow + Adult Nasal Cannula | 423 | 4 | 2.6% |
| Myairvo Humidifier | 348 | 0 | 0.3% |
| Fisher and Paykel Healthcare | 333 | 134 | 0% |
| Adult Breathing Circuit | 292 | 0 | 0.7% |
| Adult Dual Heated Breathing Circuit | 232 | 0 | 0% |
| Autofeed Humidification Chamber | 210 | 0 | 0% |
| Myairvo 2 Humidifier | 198 | 0 | 0.5% |
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 Airvo 2 Humidifier reports
How many FDA reports name Airvo 2 Humidifier?
1,970 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 (98.1%), injury (1.3%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no audible alarm (95.3%), defective alarm (2.5%), device alarm system (1.1%), no audible prompt/feedback (0.7%) and defective component (0.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Airvo 2 Humidifier 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.