Device product
Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
Z-0343-2018
Product summary
- Firm
- Vyaire Medical
- Event
- Event 78636
- Status
- Terminated
- Classification
- Class I
- Quantity
- 16,670 units in total
- Official record key
device-enforcement:Z-0343-2018
Official wording
Reason: Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.
Code information: CM17H12 CM17H16 CM17H17 CM17H19 CM17H20 CM17J27 CM17J28 CM17J29 CM17J30 CM17K09 CM17K20 CM17K21 CM17K22 CM17K23
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Manufacturing or process control
Manufacturing error