The Food and Drug Administration identifies the software update and nebulizer restrictions as the most serious type of recall.
Philips has issued a correction for its Trilogy Evo platform ventilators, an action the Food and Drug Administration (FDA) has classified as a Class I recall. This classification indicates that the use of these devices without correction could cause serious injury or death.
The recall involves correcting the devices through software updates and specific usage restrictions rather than removing them from hospitals or home care settings. Affected models include the Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal.
Issues with Nebulizer Use and Flow Sensors
The FDA identified three primary issues affecting the platform. A significant concern involves the use of non-pneumatic nebulizers, such as vibrating mesh nebulizers. Using these tools can result in a discrepancy between the set tidal volume and the volume received by the patient.
Because non-pneumatic nebulizers add liquid droplets to the airflow, the ventilator’s leak estimation calculation may become incorrect. This leads to the under-delivery of therapy even if the graphic user interface does not display a change.
Aerosol can also accumulate on the internal flow sensor depending on where a nebulizer is placed in the patient circuit. Over time, this buildup may interfere with the sensor’s ability to measure airflow accurately, potentially leading to over-delivery of tidal volume, under-delivery of oxygen, or a “Ventilatory Inoperative” condition. Potential harms include hypoventilation, low oxygen saturation, and respiratory distress.
Alarm Delays and Patient Safety
The correction also addresses an issue where the obstruction alarm may not trigger within the required timeframe of two breath cycles or five seconds. In certain ventilation modes, the alarm could be delayed by up to four breaths.
As of March 6, Philips has reported three serious injuries and no deaths associated with these issues. The ventilators provide support for pediatric through adult patients weighing at least 2.5 kg and are used in hospitals, health care settings, and for patient transport.
What to Do
Philips sent a letter to affected customers recommending several immediate actions to ensure patient safety, including updating all Trilogy Evo platform ventilators to software version 1.05.15.00, which is available as a free download.
Additionally, Philips says to stop all use of non-pneumatic nebulizers with the affected ventilators. Organizations should communicate this notice to all staff who interact with the devices, including clinicians, therapists, and nurses, to ensure they are aware that non-pneumatic nebulizers are prohibited.
The company also advises customers to review the latest user manual addendum and ensure a copy is included with every ventilator in their fleet. If a ventilator has been transferred to another organization, the information and addendum must be communicated to the new owners, Philips says.
