MAUDE manufacturer profile
RESPIRONICS, INC. · NOU
MAUDE profile for Continuous, Ventilator, Home Use
Key facts
| Manufacturer | RESPIRONICS, INC. |
|---|---|
| Manufacturer group | RESPIRONICS, INC. |
| Product code | NOU |
| Product code name | Continuous, Ventilator, Home Use |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, Particulates, Adverse Event Without Identified Device or Use Problem, No Audible Alarm, Improper or Incorrect Procedure or Method, Device Alarm System, Key or Button Unresponsive/not Working, Tidal Volume Fluctuations 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