MAUDE manufacturer profile
NEWPORT MEDICAL INSTRUMENTS, INC. · NOU
MAUDE profile for Continuous, Ventilator, Home Use
Key facts
| Manufacturer | NEWPORT MEDICAL INSTRUMENTS, INC. |
|---|---|
| Manufacturer group | NEWPORT MEDICAL INSTRUMENTS, INC. |
| Product code | NOU |
| Product code name | Continuous, Ventilator, Home Use |
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 Patient Involvement, Device Displays Incorrect Message, No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, No Consequences Or Impact To Patient, No Display/Image, Application Interface Becomes Non-Functional Or Program Exits Abnormally, Device Inoperable 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