MAUDE manufacturer profile
NIHON KOHDEN AMERICA · MHX
MAUDE profile for Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Key facts
| Manufacturer | NIHON KOHDEN AMERICA |
|---|---|
| Manufacturer group | NIHON KOHDEN AMERICA |
| Product code | MHX |
| Product code name | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
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 Known Impact Or Consequence To Patient, Device Inoperable, No Clinical Signs, Symptoms or Conditions, Communication or Transmission Problem, Computer Software Problem, Malposition of Device, Wireless Communication Problem, No Display/Image 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