Device product
NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Z-1224-2022
Product summary
- Event
- Event 90163
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29 units
- Official record key
device-enforcement:Z-1224-2022
Official wording
Reason: Software anomaly was identified.
Code information: Model Number: NIM4CPB1; UDI/DI: 00763000002985, lot numbers: P1910256, P1910260, P1910402, P1910404, P2008073, P2008130, P2008131 and 00763000395902, lot numbers: P2026275, P2026290, P2026329, P2026330, P2026357, P2026388, P2026389, P2026680, P2026681, P2026718, P2026719, P2026793, P2026956, P2026957, P2026958, P2026959, P2026981, P2026994, P2026995, P2127005, P2127006, P2127013
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
Derived failure modes
-
Device software or design
Software anomaly