MAUDE manufacturer profile
VYAIRE MEDICAL · BTT
MAUDE profile for Humidifier, Respiratory Gas, (Direct Patient Interface)
Key facts
| Manufacturer | VYAIRE MEDICAL |
|---|---|
| Manufacturer group | LABORATORIOS PISAÂ |
| 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 Clinical Signs, Symptoms or Conditions, Contamination /Decontamination Problem, Device Operates Differently Than Expected, Low Oxygen Saturation, No Known Impact Or Consequence To Patient, Leak/Splash, Fitting Problem, Defective Device 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