MAUDE manufacturer profile
GE MEDICAL SYSTEMS ULTRASOUND&PRIMARY CARE DIAGLLC · FMZ
MAUDE profile for Incubator, Neonatal
Key facts
| Manufacturer | GE MEDICAL SYSTEMS ULTRASOUND&PRIMARY CARE DIAGLLC |
|---|---|
| Manufacturer group | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC |
| Product code | FMZ |
| Product code name | Incubator, Neonatal |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Insufficient Flow or Under Infusion, Microbial Contamination of Device, No Flow, Contamination /Decontamination Problem, Adverse Event Without Identified Device or Use Problem, 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