Device product
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Z-2654-2023
Product summary
- Event
- Event 93020
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13 total devices
- Official record key
device-enforcement:Z-2654-2023
Official wording
Reason: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Code information: UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249
Distribution pattern: Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
Derived failure modes
-
Device software or design
software issue