MAUDE manufacturer profile
SPACELABS HEALTHCARE · MHX
MAUDE profile for Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Key facts
| Manufacturer | SPACELABS HEALTHCARE |
|---|---|
| Manufacturer group | SPACELABS HEALTHCARE |
| Product code | MHX |
| Product code name | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Communication or Transmission Problem, No Display/Image, Unexpected Shutdown, Application Program Freezes, Becomes Nonfunctional, No Consequences Or Impact To Patient, Device Alarm System 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