Cardiac Monitoring Software Failed to Properly Route ECG Events
Braemar Manufacturing's Monitoring Service Application (versions 6.5-7.4) failed to properly route and review ECG events from July 2022-July 2024 due to a disabled analysis step. This affected about 130,000 units with 41,282 customers nationwide.
- Product
- Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
- Category
- Medical Device
- Distribution
- Distributed nationwide