Devices › Humidifier, respiratory gas, (direct patient interface)
Device brand name · Respiratory humidifier
Fisher & Paykel Healthcare: medical device reports filed with FDA
4,780 reports name it, 2007–2026. Manufacturer given most often on reports: Fisher & Paykel Healthcare. Product code BTT.
- 4,780
- device reports naming the brand
- 0% of all MAUDE reports · about 245 a year
- 3,374
- reports, 12 months to August 2026
- 959 in the 12 months before
- 98.9%
- classified as malfunction
- 96.1% across the product code
- 0.3%
- classified as death, as reported
- 12 reports · not verified by FDA
FDA's MAUDE database holds 4,780 reports that name the brand "Fisher & Paykel Healthcare" (respiratory humidifier), received between January 2007 and August 2026; the manufacturer given most often on reports is Fisher & Paykel Healthcare. Spellings of one product vary from report to report.
3,374 reports arrived in the 12 months to August 2026, up 252% from 959 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 (98.9%), injury (0.8%) and death (0.3%); 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 defective alarm (58.7%), no audible alarm (6.5%) and pressure problem (5.8%). The patient problems coded most often are low oxygen saturation, hypoxia and pneumothorax. 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 |
|---|---|---|---|
| Defective alarm | 2,807 | 58.7% | 15.7% |
| No audible alarm | 313 | 6.5% | 25.2% |
| Pressure problem | 279 | 5.8% | 0.1% |
| Gas/air leak | 264 | 5.5% | 1% |
| Material split, cut or torn | 248 | 5.2% | 3.7% |
| Crackthe device cracked | 195 | 4.1% | 4.8% |
| Leak/splashthe device leaked | 186 | 3.9% | 6.2% |
| Breakthe device broke | 184 | 3.8% | 4.3% |
| Fluid/blood leak | 146 | 3.1% | 5.4% |
| Detachment of device or device componentpart of the device came off | 104 | 2.2% | 2.9% |
| Melted | 60 | 1.3% | 1.5% |
| Mechanical problema mechanical problem | 42 | 0.9% | 0.6% |
| Stretched | 36 | 0.8% | 0.3% |
| Device dislodged or dislocated | 33 | 0.7% | 0.2% |
| Insufficient device problem information | 28 | 0.6% | 0.5% |
| Unintended movement | 26 | 0.5% | 0.1% |
| Connection problema connection problem | 22 | 0.5% | 1.7% |
| Material puncture/hole | 20 | 0.4% | 0.3% |
| Loose or intermittent connection | 15 | 0.3% | 0.3% |
| Disconnection | 10 | 0.2% | 0.9% |
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 |
|---|---|---|
| Low oxygen saturation | 83 | 1.7% |
| Hypoxialow oxygen | 6 | 0.1% |
| Pneumothoraxa collapsed lung | 5 | 0.1% |
| Bradycardiaslow heart rate | 4 | 0.1% |
| Airway obstruction | 3 | 0.1% |
| Superficial (first degree) burn | 3 | 0.1% |
| Aspiration/inhalation | 2 | 0% |
| Burn(s)a burn | 2 | 0% |
| Internal organ perforation | 2 | 0% |
| Respiratory failurethe lungs could not supply enough oxygen | 2 | 0% |
| Abnormal blood gases | 1 | 0% |
| Abrasion | 1 | 0% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0% |
| Cardiac arrestthe heart stopped | 1 | 0% |
| Coughcough | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Fisher & Paykel Healthcare | Product code BTT | All MAUDE reports |
|---|---|---|---|
| Reports | 4,780 | 18,530 | 26,136,888 |
| Share of that pool | — | 25.8% | 0% |
| Classified as death, per 1,000 reports | 3 | 7 | 9 |
| Classified as injury | 0.8% | 2.2% | 36.2% |
| Classified as malfunction | 98.9% | 96.1% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 |
|---|---|---|---|
| Airvo 2 Humidifier | 1,970 | 0 | 0.6% |
| 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 Fisher & Paykel Healthcare reports
How many FDA reports name Fisher & Paykel Healthcare?
4,780 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3,374 in the latest 12 months.
What kinds of events are reported?
malfunction (98.9%), injury (0.8%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
defective alarm (58.7%), no audible alarm (6.5%), pressure problem (5.8%), gas/air leak (5.5%) and material split, cut or torn (5.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Fisher & Paykel Healthcare 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.