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The Dutch medtech giant has informed the FDA that reworked Philips Respironics Trilogy ventilators have two new potential issues, the FDA said last week. Philips followed up today with a news release that said the Trilogy 100/200 ventilators with potential additional problems make up roughly 3% of the 5.5 million respiratory devices in the original recall. (That comes to roughly 165,000 devices.) Urethane Rubber Sheet
First, the new silicone sound abatement foam could separate from the plastic backing. The separated foam could impact device performance. For example, the silicone foam could potentially block the air inlet, lowering the inspiratory pressure. A ventilator alarm, such as the Low Inspiratory Pressure alarm, could sound. Philips installed silicone foam in the reworked ventilators to replace the polyester-based polyurethane (PE-PUR) foam that could potentially deteriorate and get into air pathways.
In addition, the company reported trace amounts of particulate matter in the air pathway of some corrected ventilators in the U.S. Particulate samples went to a third-party lab for evaluation. Preliminary results showed PE-PUR and environmental debris in some samples. In others, there was only environmental debris.
The FDA wants Philips to provide additional information so that it can understand what caused the new issues. The agency said it wants to provide informed recommendations to patients, caregivers and healthcare professionals.
Philips said it has received a limited number of complaints from the U.S. and Japan about the new problems. It says the issues are only related to corrected ventilators. It has temporarily suspended the repair of Trilogy 100/200 devices while it investigates the potential problems.
Since April 2021, the FDA has received more than 69,000 medical device reports, including 168 reports of death, related to sound abatement foam breaking down in CPAP and BiPAP ventilators and other respiratory devices. (Note: The FDA’s MDR system is a passive system with limitations.)
In addition to consent decree talks with the DOJ and FDA, Philips also faces lawsuits.
The company said last month that it has produced roughly 4 million replacement devices and repair kits for the sound abatement foam recall. Philips Respironics said at the time that the goal is to complete about 90% of the production and shipments to customers this year.
However, additional problems are coming out. In addition to the new problems with remediated devices, Philips Respironics has warned about CPAP or BiPAP therapy masks with magnetic headgear clips or straps. The magnets could negatively interact with implantable, metallic medical devices. FDA designated the masks recall as Class I last week.
This story originally ran on Nov. 18, 2022. Updated Nov. 21 with additional information from Philips.
Filed Under: Featured, Food & Drug Administration (FDA), News Well, Recalls, Regulatory/Compliance, Respiratory Tagged With: Philips
Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at firstname.lastname@example.org.
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