FDA Warns Public Over Philips Ventilator Replacement Foam

FDA Warns Public Over Philips Ventilator Replacement Foam

Coming off of yet another recall in September, Philips now faces even more issues with its ventilators. Philips originally recalled millions of its sleep apnea and ventilator machines in June 2021. Shortly after it initiated the recall, the health technology company began repairing and replacing these devices. On November 17, the FDA notified the public that certain reworked Philips ventilators had two new potential problems. The company currently faces hundreds of lawsuits filed in state and federal courts arising from injuries caused by the degrading foam within the machines. This FDA update is one of several since the 2021 recall, highlighting the consistent product defects of Philips ventilators and sleep apnea devices. 

Philips Recalled Millions of Sleep Apnea Machines and Ventilators in 2021

Philips recalled millions of devices designed to assist patients with breathing in June 2021. The recall affected various models of CPAP, BiPAP, and ventilator machines that contained polyester-based polyurethane (PE-PUR) foam. Philips lined the machines with this sound abatement foam to reduce noise and vibration for users. However, the company discovered that the PE-PUR foam breaks down when exposed to hot and humid conditions. 

Users can swallow or inhale the black pieces of foam or toxic particles when the foam degrades. The FDA labeled this recall as a Class I because these issues could result in serious injury and require medical intervention to prevent permanent injury. These hazards prompted individuals to file lawsuits nationwide. Lawsuits cite cancer, organ damage, respiratory issues, and pulmonary fibrosis as injuries users have suffered due to the faulty sound abatement foam. 

The FDA recently updated its medical device reports associated with the foam breakdown to reflect numbers received from August 1, 2022, and October 31, 2022. With this new information, since April 2021, the FDA has received more than 90,000 MDRs, including 260 reports of death reportedly linked to Philips sleep apnea and ventilator machines. 

New Problems Linked to Philips Respironics Trilogy Ventilators 

Philips’ attempts to rectify the issues with its ventilators and sleep apnea machines have been a drawn-out process. By August 2022, the FDA revealed it had received over 69,000 adverse health reports, including 168 deaths, related to Philips devices. In September 2022, Philips pulled millions of CPAP and BiPAP masks that contained magnets. These magnets could interfere with vital metallic implants of users or those nearby such as pacemakers or insulin pumps. 

Amid all of these controversies, Philips recently informed the FDA that the repaired Philips Respironics Trilogy Ventilator presents two major problems. Firstly, Philips replaced the PE-PUR foam with silicone sound abatement foam. Yet, this silicone foam can separate from the plastic backing and block the air inlet. This blockage can dangerously lower the amount of air getting to the patient. Ideally, the Low Inspiratory Pressure alarm will sound if the blockage significantly impacts the air pressure. 

The second issue is trace amounts of particulate matter have been found in the air pathways of the reworked ventilators. A third-party lab evaluated samples and identified PE-PUR and environmental debris in some samples. 

The FDA stated that it will update the public once more information becomes available.