MAUDE manufacturer profile
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION · DTQ
MAUDE profile for Console, Heart-Lung Machine, Cardiopulmonary Bypass
Key facts
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
|---|---|
| Manufacturer group | SAME |
| Product code | DTQ |
| Product code name | Console, Heart-Lung Machine, Cardiopulmonary Bypass |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, No Patient Involvement, Output Problem, Device Alarm System, Device Operates Differently Than Expected, Display or Visual Feedback Problem, Device Displays Incorrect Message 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