MAUDE manufacturer profile
MERGE HEALTHCARE · DQK
MAUDE profile for Computer, Diagnostic, Programmable
Key facts
| Manufacturer | MERGE HEALTHCARE |
|---|---|
| Manufacturer group | MERGE HEALTHCARE |
| Product code | DQK |
| Product code name | Computer, Diagnostic, Programmable |
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 Known Impact Or Consequence To Patient, Application Interface Becomes Non-Functional Or Program Exits Abnormally, Device Issue, Device Operational Issue, No Clinical Signs, Symptoms or Conditions, Failure to Transmit Record, Data Problem, Application Program 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