FDA Scrambling After Hundreds Die From Recalled Sleep Machine

The Food and Drug Administration (FDA) has recently disclosed that a total of 561 fatalities have been linked to the use of recalled Philips devices designed to treat obstructive sleep apnea and various respiratory conditions.

Since April 2021, the FDA has logged over 116,000 cases where the foam in Philips CPAP machines and BiPAP sleep therapy devices has broken down. This serious issue caused the medical device producer from the Netherlands to recall millions of these devices due to the risk of users breathing in or being exposed to particles of gas and foam.

The main worry stems from the disintegration of the polyester-based polyurethane foam utilized in these devices to minimize noise and vibration. This degradation can result in the formation of black particles or the release of unseen chemicals, which users may breathe in or swallow. The FDA has warned that these problems might cause severe injuries, necessitating medical treatment to avoid lasting damage.

In response to these alarming events, Philips has decided to halt the sale of these machines in the United States. The company has settled with the FDA and the Justice Department, which is expected to result in a financial loss of approximately $400 million, as disclosed in a regulatory filing.

To compensate for the damages caused, Philips agreed to pay at least $479 million to users of 20 different breathing devices and ventilators sold in the U.S. between 2008 and 2021. In September, a proposed class-action settlement was reached, allowing individuals who experienced financial losses from purchasing, leasing, or renting the recalled machines to file claims.

Individuals affected are eligible for different types of compensation, such as a Device Payment Award for every recalled device they bought, leased, or rented, a $100 Device Return Award for each recalled device returned by August 9, 2024, and a Device Replacement Award covering the expense of acquiring an equivalent device between June 14, 2021, and September 7, 2023, as a substitute for a recalled unit.

Despite the severity of the situation, Philips has stated that it has investigated all allegations and complaints of malfunction, severe injury, or death and has found no conclusive data linking the devices to the reported deaths.