Trilogy ventilators manufactured by Philips Respironics has received the highest-risk label possible from the government regulator. A Class 1 label from the Food and Drug Administration applies to products the FDA deems may pose a threat of injury or death to people using the product under normal conditions.
Officials at the agency are concerned about a possibly faulty component, which could make breathing difficult or impossible using the device. According to the government watchdog, a faulty alarm on the Trilogy ventilators may fail to sound an alarm, preventing patients from knowing when the device failed. The manufacturer has responded to the classification. Company managers blame a component which comprises part of the power management board for the product.
They say the problem was first discovered during testing, in models 100, 200 and 202. The company then initiated a recall of the affected ventilators. Around 6000 of the devices were sold in the last year, around the United States and to customers in several other countries. They were sold throughout 2013, and in January 2014.
This is the second major recall for the manufacturer in the last year. The FDA issued a similar warning about the V60 model of respirator manufactured by Philips. A problem with that design was also tied to power management systems aboard the devices. That was a larger recall, affecting 19,000 copies of the faulty ventilator.