Device product
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Z-2007-2023
Product summary
- Event
- Event 92300
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 software versions
- Official record key
device-enforcement:Z-2007-2023
Official wording
Reason: Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.
Code information: UDI/DI 00887761985193, Software Versions: 3.9: 3.9.200,3.9.201, 3.9.300, 3.9.400, 3.9.401, 3.9.500, 3.9.600
Distribution pattern: US Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.
Derived failure modes
-
Unknown
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.