Derived label

Device software or design

The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software defect may cause incorrect
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Visicu, Inc.