MAUDE manufacturer profile
BARD ACCESS SYSTEMS · IYO
MAUDE profile for System, Imaging, Pulsed Echo, Ultrasonic
Key facts
| Manufacturer | BARD ACCESS SYSTEMS |
|---|---|
| Manufacturer group | DYMAX CORP. |
| Product code | IYO |
| Product code name | System, Imaging, Pulsed Echo, Ultrasonic |
At a glance
- 1,000+ MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Battery Problem, Loss of Power, Poor Quality Image, No Display/Image, Image Display Error/Artifact, Charging 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