MAUDE manufacturer profile
INSIGHTRA MEDICAL · DSP
MAUDE profile for System, Balloon, Intra-Aortic And Control
Key facts
| Manufacturer | INSIGHTRA MEDICAL |
|---|---|
| Manufacturer group | INSIGHTRA |
| Product code | DSP |
| Product code name | System, Balloon, Intra-Aortic And Control |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Inflation Problem, Device Displays Incorrect Message, Device Operates Differently Than Expected, Positioning Problem, Leak/Splash, Fluid/Blood Leak, Failure of Implant 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