MAUDE manufacturer profile
IRHYTHM TECHNOLOGIES, INC · QYX
MAUDE profile for Outpatient Cardiac Telemetry
Key facts
| Manufacturer | IRHYTHM TECHNOLOGIES, INC |
|---|---|
| Manufacturer group | IRHYTHM TECHNOLOGIES, INC |
| Product code | QYX |
| Product code name | Outpatient Cardiac Telemetry |
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
- Unspecified Heart Problem, Failure to Transmit Record, Patient-Device Incompatibility, Skin Inflammation/ Irritation, Adverse Event Without Identified Device or Use Problem, Insufficient Information, Inaccurate Information, Hypersensitivity/Allergic reaction 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