Philips Respironics recently announced a mandatory software correction and updates to its instructions for use for the Trilogy Evo, EV300, Evo02, and Evo Universal ventilators. These updates aim to resolve several safety issues that could affect the devices’ ability to support patient breathing. The company stated that the software updates and instructions addendum will address multiple reported safety issues.
These issues include inaccurate display of oxygen delivered, false power loss or battery depleted alarms, and flow sensor reading compensation problems. Other concerns involve software alarm errors, technical alarm threshold adjustments, and user interface issues. The instructions will also include information about the accumulation of environmental debris on the internal machine flow sensor, which could potentially block pressure, volume, or airflow.
Philips has received nine reports of injury and one death associated with these issues.
Philips Respironics software update details
The company recommends that healthcare providers ensure the Trilogy ventilators have been successfully updated to version 1.05.10.00 in the US and that they are aware of the user manual addendum.
The FDA recently designated this recall as Class I, the most serious level due to potential health hazards. The recall affects approximately 90,000 units globally, with about 67,000 of these in the US. In response, Philips Respironics sent an Urgent Medical Device Correction on July 16, advising all affected customers to immediately update their device software to the latest version.
Customers are also recommended to follow a user manual addendum that mandates a Philips-approved particulate filter to prevent environmental contamination. Philips emphasized that its Respironics division is reinforcing efforts to enhance patient safety and product quality. These endeavors have led to more frequent updates on identified issues, including corrective actions for previous field safety notices.
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