MAUDE manufacturer profile
QUEST MEDICAL, INC. · DTR
MAUDE profile for Heat-Exchanger, Cardiopulmonary Bypass
Key facts
| Manufacturer | QUEST MEDICAL, INC. |
|---|---|
| Manufacturer group | QUEST MEDICAL, INC. |
| Product code | DTR |
| Product code name | Heat-Exchanger, Cardiopulmonary Bypass |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, Fluid/Blood Leak, No Clinical Signs, Symptoms or Conditions, Device Operates Differently Than Expected, Leak/Splash, Blood Loss 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