The FDA recently announced recalls for multiple sleep apnea machine models, citing potential safety risks for users. Tragically, the malfunction has led to the deaths of at least 561 individuals, with an additional 116,000 incidents reported since April 2021. The problem stems from a foam element intended to reduce vibrations and noise in the device, which can degrade and emit dangerous substances and particles into the airway.
The FDA initially made an announcement in June 2021, but has since gathered additional data, leading to a recent update in communication. The affected devices, all manufactured by Philips Respironics, include respirators, bilevel positive airway pressure (biPAP) machines, and continuous positive airway pressure (CPAP) machines.
The deterioration of the foam, composed of polyester-based polyurethane, poses various potential dangers. Individuals may inadvertently ingest or inhale small particles of the material, resulting in airway irritation, headaches, asthma, inflammatory reactions, and toxic effects on essential organs.
Furthermore, this process may emit detrimental fumes into the air pathway, subjecting the user to chemical substances capable of inducing the aforementioned symptoms. Moreover, individuals may encounter dizziness, heightened sensitivity reactions, and feelings of nausea or vomiting. Utilizing ultraviolet light and ozone devices, which lack FDA approval, for sanitizing machine components could heighten the associated risks.
Another recall concerning reworked Philips Respironics Trilogy 100/200 Ventilators warns that the silicone foam employed as a substitute for the polyester-based polyurethane components might also dislodge and shift, potentially obstructing the air passage.
Typically, when a malfunction occurs, the machine will emit an alarm. However, there are instances where users may not hear or react to the alert, potentially resulting in life-threatening breathing issues due to the obstruction. It’s important to note that this recall specifically concerns ventilators, with no impact on BiPAP and CPAP machines.