Device product
Adult AirLife dual-limb, dual-heat circuit (Model AH280) 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-0346-2018
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-0346-2018
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: 0001100127 0001116871 0001116872 0001124936 0001129065 0001129066 0001129067 0001129069 0001129070 0001131426 0001131428 0001134350 0001135400 0001136027 0001136028 0001136029 0001145151 0001145152 0001145153 0001157125
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Manufacturing or process control
Manufacturing error