MAUDE manufacturer profile
SPACELABS HEALTHCARE · DSI
MAUDE profile for Detector And Alarm, Arrhythmia
Key facts
| Manufacturer | SPACELABS HEALTHCARE |
|---|---|
| Manufacturer group | SPACELABS HEALTHCARE |
| Product code | DSI |
| Product code name | Detector And Alarm, Arrhythmia |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Device Alarm System, No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, No Clinical Signs, Symptoms or Conditions, Reset Problem, Death, Defective Alarm 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