MAUDE manufacturer profile
ACIST MEDICAL SYSTEMS · IZQ
MAUDE profile for Injector, Contrast Medium, Automatic
Key facts
| Manufacturer | ACIST MEDICAL SYSTEMS |
|---|---|
| Manufacturer group | ACIST MEDICAL SYSTEMS |
| Product code | IZQ |
| Product code name | Injector, Contrast Medium, Automatic |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Air Embolism, Insufficient Information, Myocardial Infarction, Chest Pain, Cardiac Arrest, No Clinical Signs, Symptoms or Conditions, Break 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