MAUDE manufacturer profile
NIHON KOHDEN ORANGEMED, INC. · CBK
MAUDE profile for Ventilator, Continuous, Facility Use
Key facts
| Manufacturer | NIHON KOHDEN ORANGEMED, INC. |
|---|---|
| Manufacturer group | NIHON KOHEN ORANGEMED, INC. |
| Product code | CBK |
| Product code name | Ventilator, Continuous, Facility Use |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Defective Component, Inappropriate or Unexpected Reset, Insufficient Information, Gas/Air Leak, Low Oxygen Saturation, Computer Software Problem, Unexpected Shutdown 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