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PHILIPS RESPIRONICS CPAP INFORMATION
On June 30, 2021, the United States Food and Drug Administration (FDA) issued an official communication recalling certain Philips Respironics ventilators, BiPAP, and CPAP machines. Subsequently, on July 22, 2021, the FDA issued another official communication identifying the recall as a Class I recall, “the most serious type of recall” because certain Philips Respironics devices “may cause serious injuries or death.” The Philips devices have a foam component that reduces sounds from the Philips Respironics device. This foam does degrade (break down) into particles which may be inhaled or swallowed by users, or release volatile organic compounds (VOCs) that may be inhaled, which could lead to negative health effects. Preliminary laboratory analysis by Philips determined that extreme operating temperatures and ozone cleaning methods may increase the breakdown of the foam. The company recommends against product use in temperatures outside of the labelled operating conditions, and the use of non validated cleaning methods, such as ozone. Philips has issued letters to customers, patients, and distributors with instructions for the recall. Philips indicates it will replace the foam component with a material that is not affected by this issue, or it will replace affected devices altogether. Philips reports that they have received a relatively low number of complaints, some of which relate to black debris in the device air path, including the tubing and mask. Some users have reported headache, upper airway irritation, cough, chest pressure, and sinus infection, but it is has not yet been determined if degraded foam particles or Volatile Organic Compounds were the cause.
PLEASE DO NOT CALL OR SPEAK WITH ANYONE FROM PHILLIPS REGARDING YOUR CPAP MACHINE. THEY ARE RECORDING YOU AND MAY USE YOUR STATEMENT LATER AGAINST YOU.
DO NOT POST ANYTHING ON SOCIAL MEDIA REGARDING THIS MATTER, YOUR HEALTH CONDITION OR ANYTHING THAT MIGHT BE RELATED TO PHILIPS OR YOUR MACHINE!