MAUDE manufacturer profile
RESPIRONICS CALIFORNIA, LLC · MNT
MAUDE profile for Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Key facts
| Manufacturer | RESPIRONICS CALIFORNIA, LLC |
|---|---|
| Manufacturer group | RESPIRONICS CALIFORNIA, LLC |
| Product code | MNT |
| Product code name | Continuous, Minimal Ventilatory Support, Facility Use Ventilator |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Patient Involvement, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, No Consequences Or Impact To Patient, Inadequate User Interface, Defective Component, Device Operates Differently Than Expected 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