More than a year after Philips Respironics recalled 3.5 million ventilators, the devicemaker told the FDA two new potential issues have appeared in reworked ventilators, the agency said Nov. 17.
One possible issue is the silicone sound abatement foam breaking off from the plastic backing, which could block the air vent and significantly lower the air pressure. The second potential problem stems from traces of particulate matter, which were found in air pathways of some reworked ventilators. Samples of the particulate matter were sent to a third-party lab for inspection, according to the FDA.
In the original recall, Philips Respironics pulled multiple BPAP and CPAP products off the market because the foam that was used to reduce sound and vibration could break down and black debris could be ingested.
The FDA said it is working with the company to "better understand the cause of the issues."