MAUDE manufacturer profile
BREAS MEDICAL AB · NOU
MAUDE profile for Continuous, Ventilator, Home Use
Key facts
| Manufacturer | BREAS MEDICAL AB |
|---|---|
| Manufacturer group | BREAS MEDICAL AB |
| Product code | NOU |
| Product code name | Continuous, Ventilator, Home Use |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Information, Device Displays Incorrect Message, No Known Impact Or Consequence To Patient, Insufficient Information, No Clinical Signs, Symptoms or Conditions, Device Operates Differently Than Expected, Failure to Charge, Device Alarm System 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