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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00102-1
Product Name/Description	paraPAC plus Ventilator Model: 310 Product Code: P310NAU ARTG 334236 (Smiths Medical Australasia Pty Ltd - Portable pneumatic ventilator)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	14/02/2024
Responsible Entity	Smiths Medical Australasia Pty Ltd
Reason/Issue	When a paraPAC plus ventilator is switched to the operating mode of ‘Ventilate’ the device may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed. If the ventilator experiences the continuous positive gas flow instead of intended cycling like a human breath, it may result in delay of therapy, no ventilation, excessive tidal volume or excessive pressure. If the device does not allow for adequate expiration of the respiratory cycle, this may lead to hypoxia. These situations may potentially lead to serious patient injury or death, depending on the clinical situation.
Recall Action	Product Defect Alert
Recall Action Instructions	A correction to fix this problem is currently being investigated and customers will be contacted when more information is available. In the interim Smiths Medical advises users to: Follow all instructions, including warnings and cautions in the User Manual with heightened awareness. This is inclusive, but not limited to the following: • Constant monitoring of the patient • Blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography. • All pre-use checks must be performed before each use. • Alternative means of ventilation such as bag mask ventilation, must be available in the event of ventilator failure or malfunction.
Contact Information	02-8335-1010 - Smiths Medical