Device product
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.
Z-2935-2020
Product summary
- Event
- Event 85997
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 680 units
- Official record key
device-enforcement:Z-2935-2020
Official wording
Reason: Infusion pump component defect may result in interruption of patient monitoring
Code information: Model: EtCO2 8300; Lot/Serial numbers: 10002682711, 10002720508, 1000287042, 10002882569
Distribution pattern: U.S. Nationwide distribution including in the states of AZ, CA, FL, GA, IA, ID, IL, KS, LA, MI, MN, MO, MS, MT, NC, NE, NV, NY, OH, PA, SC, TX, WA, WI. OUS.: None
Derived failure modes
-
Unknown
Infusion pump component defect may result in interruption of patient monitoring