MAUDE manufacturer profile
EDWARDS LIFESCIENCES · DQK
MAUDE profile for Computer, Diagnostic, Programmable
Key facts
| Manufacturer | EDWARDS LIFESCIENCES |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES |
| Product code | DQK |
| Product code name | Computer, Diagnostic, Programmable |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Incorrect Measurement, Incorrect, Inadequate or Imprecise Result or Readings, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, No Device Output, Appropriate Term/Code Not Available, Output Problem 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