U.S. agency reveals 8,000 new reports health problems tied to Philips ventilators

Philips was linked to over 8,000 new reports of problems patients may have faced in November and December as the result of faulty breathing assistance devices. These cases include 82 people who died, said the U.S. Food and Drug Administration, bringing the number of deaths reported to the agency to 346. Philips said it has not yet been proven that the deaths were caused by problems with the machines.

The devices use polyurethane foam to reduce sounds and vibrations, which can break down. “If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury,” the FDA said. Philips has already recalled 5.5 million devices.

Health risks linked to inhaling or ingesting pieces of polyurethane foam include issues with toxicity in organs that can eventually lead to cancer, including cancer of the kidneys or liver. Asthma, headaches, inflammatory response, airway irritation, and irritation to the skin, eyes, and nose can also occur. If the foam releases chemicals in the device’s air tubes, it can cause the same health issues, as well as dizziness, allergic reaction, immune system reactions, nausea, and vomiting.

In some cases, the silicone foam used to replace the potentially harmful polyurethane can also cause problems. The FDA said, “the foam in the reworked ventilators may potentially move and block the airpath, which may reduce airflow in the ventilator and could also cause the device to alarm.”

The FDA has periodically updated its bulletin over the Philips Respironics ventilators, bilevel positive airway pressure machines, and continuous positive airway pressure machines. Philips said that over 90 percent of nearly 100,000 incidents reported over the last 22 months had no serious consequences.