MAUDE manufacturer profile
RESPIRONICS CALIFORNIA, INC. · CBK
MAUDE profile for Ventilator, Continuous, Facility Use
Key facts
| Manufacturer | RESPIRONICS CALIFORNIA, INC. |
|---|---|
| Manufacturer group | RESPIRONICS CALIFORNIA, LLC |
| Product code | CBK |
| Product code name | Ventilator, Continuous, Facility Use |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, Failure to Power Up, Device Displays Incorrect Message, Device Inoperable, No Consequences Or Impact To Patient, No Display/Image 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