Device product
Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home. Patients can review their stored vital sign measurements (captured outside of Health Harmony Mobile) and receive educational and motivational content from caregivers.
Z-2442-2018
Product summary
- Event
- Event 80382
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1302
- Official record key
device-enforcement:Z-2442-2018
Official wording
Reason: It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend database, resulting in the patient's clinician not getting patient data tor one or two days.
Code information: Version v 2.5.2.29
Distribution pattern: US Nationwide Distribution in the states of CO, ID, PA, and LA
Derived failure modes
-
Unknown
It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend database, resulting in the patient's clinician not getting patient data tor one or two days.