MAUDE manufacturer profile
SORIN GROUP ITALIA S.R.L. - CRM FACILITY · MWJ
MAUDE profile for Electrocardiograph, Ambulatory (Without Analysis)
Key facts
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
|---|---|
| Manufacturer group | ASICA ZAC DE LA MOINERIE 35400 SAINT MALO FRANCE |
| Product code | MWJ |
| Product code name | Electrocardiograph, Ambulatory (Without Analysis) |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Information, Overheating of Device, Temperature Problem, No Clinical Signs, Symptoms or Conditions, Insufficient Information, Fluid/Blood Leak, Material Too Rigid or Stiff 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