MAUDE manufacturer profile
GE VINGMED ULTRASOUND AS · ITX
MAUDE profile for Transducer, Ultrasonic, Diagnostic
Key facts
| Manufacturer | GE VINGMED ULTRASOUND AS |
|---|---|
| Manufacturer group | GE VINGMED ULTRASOUND AS |
| Product code | ITX |
| Product code name | Transducer, Ultrasonic, Diagnostic |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Perforation of Esophagus, Adverse Event Without Identified Device or Use Problem, Bacterial Infection, Residue After Decontamination, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Loss of or Failure to Bond, Problem with Removal of Enzymatic Cleaner 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