The FDA says some Philips ventilators — reworked as part of the company’s massive respiratory device recall — have new problems.
The Dutch medtech giant has informed the FDA that reworked Philips Respironics Trilogy ventilators have two new potential issues, the FDA said yesterday.
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 reworked ventilators. 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 has more information on its website. It said it has received a limited number of complaints about the new problems.
More about the Philips Respironics recall
Last month, Philips’ new CEO Roy Jakobs publicly apologized for the Philips Respironics recalls. The recalls involve millions of CPAP and BiPAP ventilators and other respiratory devices.
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.