MAUDE manufacturer profile
DATASCOPE FAIRFIELD · DSP
MAUDE profile for System, Balloon, Intra-Aortic And Control
Key facts
| Manufacturer | DATASCOPE FAIRFIELD |
|---|---|
| Manufacturer group | DATASCOPE FAIRFIELD |
| Product code | DSP |
| Product code name | System, Balloon, Intra-Aortic And Control |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, No Patient Involvement, Moisture Damage, No Consequences Or Impact To Patient, Death, Moisture or Humidity Problem, Failure to Advance 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