Health Harmony
Care Innovations, LLC · Model Mobile RPM - Enterprise · UDI-DI 00850040853025
Description
Health Harmony Mobile is a component of the Health Harmony Remote Patient Monitoring system. It is a software client application that runs on a personal mobile device, used by patients to easily communicate and exchange information with their healthcare provider. The Health Harmony Mobile application collects patient responses to health assessment questions and receives patient vital signs from Bluetooth-connected medical measuring devices. The Mobile application automatically and securely transmits patient information to the provider. The Health Harmony Mobile application can also display educational material and other messages received from the provider, such as reminders encouraging patients to complete a health session or to take medications as ordered. Patients can read messages and send replies to the clinician, and may also accept or a decline a video conference call initiated by their clinician, directly from the Health Harmony Mobile application. The Enterprise version of Health Harmony Mobile is pre-loaded by the manufacturer on a personal mobile device that is provided to the patient in a Health Harmony Kit.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-08 | Radiometer Medical ApS | Due to potential software issue that may result in patient mix-up information. |
| 2023-02-06 | Biomerieux Inc | For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST r |
| 2021-09-02 | BioMerieux SA | Under certain conditions, there is a risk for a false negative result. |
| 2020-09-22 | Pentax of America Inc | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does |
| 2020-09-22 | Pentax of America Inc | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does |
| 2020-01-17 | Beckman Coulter Inc. | A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that |
| 2019-09-25 | ENDOTRONIX | The firm have received reports of patients myCordella Hubs fully powering themselves down without interaction from the patient or Endotronix. |
| 2019-08-08 | Radiometer Medical ApS | The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some thir |
| 2019-05-20 | Opternative Inc | Lack of 510K clearance |
| 2017-12-06 | Intel-GE Care Innovations LLC | 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 back |
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