MAUDE manufacturer profile
AMBU A/S · BTM
MAUDE profile for Ventilator, Emergency, Manual (Resuscitator)
Key facts
| Manufacturer | AMBU A/S |
|---|---|
| Manufacturer group | AMBU LTD. |
| Product code | BTM |
| Product code name | Ventilator, Emergency, Manual (Resuscitator) |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Cardiac Arrest, Insufficient Information, Low Oxygen Saturation, Inflation Problem, No Clinical Signs, Symptoms or Conditions, Crack, Defective Device, No Known Impact Or Consequence To Patient 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