MAUDE manufacturer profile
VOLCANO CORPORATION · IYO
MAUDE profile for System, Imaging, Pulsed Echo, Ultrasonic
Key facts
| Manufacturer | VOLCANO CORPORATION |
|---|---|
| Manufacturer group | VOLCANO CORPORATION |
| Product code | IYO |
| Product code name | System, Imaging, Pulsed Echo, Ultrasonic |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Sharp Edges, No Consequences Or Impact To Patient, No Device Output, Inaccurate Synchronization, No Patient Involvement, Overheating of Device, Visual Prompts will not Clear 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