MAUDE manufacturer profile
FISHER & PAYKEL LTD · BTT
MAUDE profile for Humidifier, Respiratory Gas, (Direct Patient Interface)
Key facts
| Manufacturer | FISHER & PAYKEL LTD |
|---|---|
| Manufacturer group | FISHER & PAYKEL HEALTHCARE LTD |
| Product code | BTT |
| Product code name | Humidifier, Respiratory Gas, (Direct Patient Interface) |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Information, Device Operates Differently Than Expected, Device Displays Incorrect Message, Low Oxygen Saturation, Use of Device Problem, Leak/Splash, Fluid/Blood Leak, Death Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1