MAUDE manufacturer profile
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. · MHX
MAUDE profile for Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Key facts
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
|---|---|
| Manufacturer group | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| Product code | MHX |
| Product code name | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Appropriate Term/Code Not Available, No Consequences Or Impact To Patient, Device Alarm System, Device Displays Incorrect Message, No Audible Alarm, Device Operates Differently Than Expected 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