Device product
eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients.
Z-1708-2017
Product summary
- Firm
- Philips Visicu
- Event
- Event 76660
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26
- Official record key
device-enforcement:Z-1708-2017
Official wording
Reason: eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.
Code information: 453564506091 eCareCoordinator
Distribution pattern: Worldwide Distribution-US Nationwide
Derived failure modes
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Device software or design
software defect