Heart Failure Monitoring System Unable to Transmit Patient Readings After Cloud Migration
The Merlin.net Heart Failure monitoring application cannot transmit patient readings after a data migration to a cloud environment. Some systems (25 total) distributed across 13 U.S. states are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a functional defect preventing patient data transmission. No illnesses or injuries have been reported. The defect prevents the device from performing its essential monitoring function, creating potential risk to patient care.
Plain-English summary
The Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) is designed to work with the CardioMEMS Hospital System (Model CM3100). These systems measure pulmonary artery pressure and provide hemodynamic data to monitor and manage patients with heart failure.
Following a data migration from on-premises servers to a cloud environment, some customers reported they were unable to transmit patient readings from their systems. This functional defect prevented normal operation of the data transmission feature.
The recall affects 25 CardioMEMS Hospital Systems (Model CM3100) distributed across 13 U.S. states: California, Connecticut, Georgia, Illinois, Michigan, Minnesota, North Carolina, New Jersey, New York, Oregon, Pennsylvania, Texas, and Washington. St. Jude Medical is the manufacturer responsible for the recall.
The recalled product
- Product
- Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (H
- Manufacturer
- St. Jude Medical
- Hazard
- transmission-failure
Distribution
Distributed in 13 states:
- CA
- CT
- GA
- IL
- MI
- MN
- NC
- NJ
- NY
- OR
- PA
- TX
- WA
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