The FDA issued a notice updating instructions for a number of ventilators made by Philips (NYSE:PHG) Respironics.
This recall involves updating instructions for devices, not removing them from use or sale. The FDA identified the recall as the most serious kind, as it may cause serious injury or death.
It relates to an October warning issued by Philips in October, notifying customers of potential issues with the use of in-line nebulizers.
Earlier in October, the FDA designated a recall of Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal ventilators as Class I, the most serious kind. The issue centered around software errors, including an inaccurate display of oxygen being delivered to the patient, false power loss or battery depleted alarms, volume measurement inaccuracies and more.
Philips a week later issued an update to its voluntary correction for the same series of devices regarding the use of in-line nebulizers. The company identified the issue in a retrospective review of flow sensor performance.
More about the latest ventilator update from Philips
The latest FDA notice affects all previously listed ventilators, as well as the Aeris EVO, Garbin Evo and LifeVent EVO2 systems. Philips warns for all users of these ventilators that nebulized aerosols accumulate over time and can permanently impact the internal flow sensor.
According to the FDA notice, Philips updated instructions for the ventilators due to the risk of aerosol deposits accumulating over time. They may accumulate on the device’s internal flow sensor when customers use in-line nebulizers in certain locations. Impacted flow sensors may cause inaccurate flow measurements. This can lead to patients inadvertently and unknowingly receiving too much air flow or not enough oxygen.
Using the he affected product may cause serious adverse health consequences. Those include respiratory discomfort, lung damage (volutrauma/barotrauma) from over-delivery of tidal volume, low oxygen saturation and/or shortness of breath (dyspnea) from therapy delays or under-delivery of oxygen and death. Philips reports four injuries related to the issue.
The company asked users to make sure to set specific alarms appropriately and have alternative sources of ventilation available. If using with a set FiO2 oxygen concentration setting, users should use continuous pulse oximetry monitoring and use an external FiO2 analyzer in specific cases.
Philips continues to battle issues with its ventilators in the wake of the 2021 recall that knocked it out of the sleep respiratory market.
