| Reason for the Action |
In response to the TGA’s post-market review of ventilators, CPAP and BiPAP devices, concerns have been raised regarding the potential for PE-PUR foam degradation.
Degradation of the PE-PUR foam from the blower module of air path elements may result in the presence of fine particulates or unacceptable VOC during use of the Monnal T60 ventilator. This may result in contamination of the patient’s upper airways with particles or hazardous chemical compounds (headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects).
No injuries, serious injuries, or patient deaths have been reported during the use of the Monnal T60 ventilator worldwide during its 10-year lifespan, nor regarding products used in the Australian market for the past 5 years.
During the TGA’s post-market review of the subject ventilators, the TGA was not satisfied with the data provided regarding the long-term safety of PE-PUR foam. This has raised concerns about the ongoing safety and durability of these devices over time. |