MAUDE manufacturer profile
NIHON KOHDEN CORPORATION · DRT
MAUDE profile for Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Key facts
| Manufacturer | NIHON KOHDEN CORPORATION |
|---|---|
| Manufacturer group | NIHON KOHDEN TOMIOKA CORPORATION |
| Product code | DRT |
| Product code name | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Overheating of Device, No Known Impact Or Consequence To Patient, Temperature Problem, Output Problem, No Consequences Or Impact To Patient, Incorrect, Inadequate or Imprecise Result or Readings, Communication or Transmission Problem 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