USA – The U.S. FDA has issued a critical safety update for several Philips Respironics ventilators, emphasizing the need to update instructions for safe usage rather than withdrawing the devices from use.
The notice applies to models like Trilogy Evo, Trilogy EV300, Aeris, Garbin Evo, and LifeVent EVO2 systems, all of which provide essential breathing support for patients at home, in hospitals, or during nonemergency transport.
This update stems from issues associated with in-line nebulizer treatments that can lead to aerosol deposits on the internal flow sensors, potentially causing inaccurate airflow measurements.
According to the FDA, such inaccuracies can result in severe health risks, including lung damage, low oxygen saturation, or even death. Four injuries linked to the problem have been reported to date.
Philips first identified the risk during a retrospective review of flow sensor performance, revealing that nebulized aerosols could permanently affect the devices’ sensors.
The FDA categorized the recall as Class I—the most serious type—due to the potential for life-threatening consequences.
In response, Philips issued an urgent medical device correction notice on October 7, instructing users to:
This safety update follows a broader recall in July, addressing software errors in Trilogy ventilator models, which included false power loss alarms and incorrect oxygen display readings.
Furthermore, Philips has been managing the fallout from its massive 2021 recall of over 15 million respiratory devices due to deteriorating soundproofing foam that posed health risks to users.
Background on Philips ventilator issues
The ventilators in question are vital for patients requiring continuous or intermittent positive airway pressure.
However, if used without updated instructions, they risk delivering too much airflow or insufficient oxygen, leading to complications like respiratory discomfort or therapy delays.
The FDA notice reiterates the importance of following revised guidelines to mitigate risks associated with flow sensor malfunctions. The safety concerns have placed additional pressure on Philips Respironics, already struggling to regain its footing in the respiratory device market following its 2021 recall debacle.
These repeated recalls have highlighted ongoing challenges in maintaining quality control in medical device manufacturing.
They underscore the importance of rigorous testing and timely updates to safeguard patient health.
As Philips continues to address these issues, users are urged to adhere to the latest safety recommendations to ensure effective and safe ventilation therapy.
