Device product
Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with 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-0344-2018
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-0344-2018
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: 0001115635 0001115640 0001124941 0001124942 0001124943 0001124944 0001129628 0001134758 0001134759
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Manufacturing or process control
Manufacturing error