MAUDE manufacturer profile
CAREFUSION · BTM
MAUDE profile for Ventilator, Emergency, Manual (Resuscitator)
Key facts
| Manufacturer | CAREFUSION |
|---|---|
| Manufacturer group | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V |
| Product code | BTM |
| Product code name | Ventilator, Emergency, Manual (Resuscitator) |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Contamination with Chemical or Other Material, Device Operates Differently Than Expected, Low Oxygen Saturation, Failure to Disconnect, Break, Product Quality Problem, No Flow 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