FDA Reveals 561 Deaths Tied to Sleep Apnea Machines

(RepublicanJournal.org) – The Federal Drug Administration (FDA) recently reported on recalls of several models of sleep apnea machines, warning of possible safety hazards for users. At least 561 people have died as a result of the malfunction, and another 116,000 incidents have been reported since April 2021. The problem stems from a foam piece in the device meant to reduce vibrations and sound, but it can break apart and release harmful compounds and debris into the air tube.

The FDA released its initial announcement in June 2021, but the agency has collected much more data since then, recently updating the communication. The devices all came from Philips Respironics, and the recall affects respirators, bilevel positive airway pressure (biPAP) machines, and continuous positive airway pressure (CPAP) machines.

The breakdown of the foam, a polyester-based polyurethane, creates multiple potential hazards. Users can ingest or aspirate tiny pieces of the material, leading to airway irritation, headaches, asthma, inflammatory responses, and toxic effects on vital organs. The process can also release harmful fumes into the air tube, exposing the user to chemical compounds that can cause the above symptoms. Additionally, some people might experience dizziness, hypersensitivity reactions, and nausea or vomiting. The use of ultraviolet light and ozone devices, which are not FDA-approved, to sanitize machine components could increase the risks.

A separate recall on reworked Philips Respironics Trilogy 100/200 Ventilators cautions that the silicone foam used to replace the polyester-based polyurethane pieces can also become dislodged and move, potentially blocking the airway. In most cases, the malfunction will result in the machine giving off an alarm, but there may be cases where users don’t hear or respond to the warning, and the blockage can lead to life-threatening breathing problems. That recall pertains only to ventilators, with BiPAP and CPAP machines both unaffected.

Consumers who believe they’ve suffered any of the listed effects can file a report with MedWatch.

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