Philips recently initiated a recall for several models of its Trilogy ventilators due to a range of issues that potentially endanger patients by not providing sufficient ventilation or oxygen. The affected models include the Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal. This recall, affecting approximately 90,000 units globally—with about 67,000 located in the U.S.—is driven by reports of one death and nine injuries linked to these defects.
Responding to these issues, Philips is directing users to install a software update designed to resolve several serious problems. These issues include the emission of false power loss alarms, inaccurate display of oxygen delivery levels, and errors in oxygen volume measurement. Furthermore, to address environmental contamination risks that can impede airflow, the use of specific Philips-approved particulate filters is now mandatory with these devices.
The recall is not only aimed at addressing previously identified safety concerns but also introduces new corrective measures. For instance, Philips has updated the ventilators’ instructions for use, adding previously missing contraindications and rectifying translation errors in the instruction manuals available in Korean, Traditional Chinese, and Spanish. These steps come after the company’s ongoing efforts to manage and rectify issues with these medical devices, including previous warnings about high oxygen concentration settings and the risk of dust and debris blockage.
The safety notice reiterated that there are no new health hazards introduced in this latest communication. It clarifies and extends prior safety notices while also providing updates about labeling and the instruction manual. Philips Respironics, a subsidiary, is spearheading these updates and addresses new non-safety related issues as well.
In addition to the specific issues with the Trilogy ventilators, Philips has been dealing with broader challenges with its range of respiratory devices. A significant concern has been the use of soundproofing foam in these devices, which could disintegrate and potentially be inhaled by patients. This issue led to a broader recall spanning Philips’ respiratory device lineup and a subsequent consent decree with the Department of Justice. Under this agreement, Philips ceased sales of most of its respiratory devices in the U.S., with commitments to repair, refund, or replace the affected units. However, the FDA has allowed the continued manufacture and distribution of certain devices deemed medically necessary, including the Trilogy ventilators highlighted in the recent recall.
Patients and healthcare providers using these ventilators are urged not to use the devices until the necessary software updates are installed and the new filtration requirements are met. This recall and the accompanying corrective actions underscore Philips’ ongoing challenges with device safety and regulatory compliance in its portfolio of respiratory care solutions. As these issues are addressed, Philips continues to work under regulatory scrutiny to ensure all safety and health standards are met to safeguard patient health.
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