MAUDE manufacturer profile
DATASCOPE CORP. - FAIRFIELD · DSP
MAUDE profile for System, Balloon, Intra-Aortic And Control
Key facts
| Manufacturer | DATASCOPE CORP. - FAIRFIELD |
|---|---|
| Manufacturer group | DATASCOPE CORP. - FAIRFIELD |
| Product code | DSP |
| Product code name | System, Balloon, Intra-Aortic And Control |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 100–999 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, Optical Problem, Leak/Splash, Pressure Problem, Difficult to Insert, No Patient Involvement, Device Contamination with Chemical or Other Material 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