MAUDE manufacturer profile
VENTLAB LLC · BTM
MAUDE profile for Ventilator, Emergency, Manual (Resuscitator)
Key facts
| Manufacturer | VENTLAB LLC |
|---|---|
| Manufacturer group | SUNMED MANUFACTURED FOR VENTLAB, LLC |
| 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
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Missing Value Reason, Device Issue, Not Applicable, Separation Failure, Break, Difficult to Remove, Device Operational Issue 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