Reports Allege Philips Withheld Evidence of Ventilator Malfunctions for 11 Years

October 2, 2023

Royal Philips has denied reports that it withheld evidence of sleep and respiratory ventilator product malfunctions for more than a decade, arguing that recent media articles mischaracterize the Amsterdam-based devicemaker’s safety history.

Philips has seen multiple recalls of its ventilators and continuous positive airway pressure therapy machines since 2021 because of polyester-based polyurethane foam — and repairs to that foam that created a new problem and new recall. Foam from some of these machines had the potential to break down, releasing pieces of black foam and toxic chemicals that could be inhaled or swallowed.

An analysis from the Pittsburgh Post-Gazette and ProPublica found that tens of thousands of reports indicate that Philips withheld over 3,700 complaints for more than 11 years from the FDA, and that the company did not begin a formal investigation until 2019, nine years after the first complaints and three years after company tests showed the foam degraded.

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