Timeline Stories
November 9, 2021
The FDA released a Form 483 inspection report based on twenty-one site inspections of Philips’s Murrysville, Pennsylvania manufacturing facility between August 26, 2021 and November 9, 2021. The report concluded that Philips knew about the foam degradation issues since 2015, but never completed a health hazard evaluation, risk analysis, or design review prior to the recall.
October 8, 2021
The Judicial Panel on Multidistrict Litigation centralized class action and personal injury lawsuits against Philips before Senior United States District Court Judge Joy Flowers Conti in the Western District of Pennsylvania for coordinated or consolidated pretrial proceedings.
September 1, 2021
Philips received authorization from the FDA to begin repair and/or replacements for DreamStation devices. The company gave affected patients no clarity on how or when they would receive replacements. This authorization also did not encompass other devices manufactured with the same PE-PUR foam.
July 22, 2021
The FDA upgraded Philips’s recall to its most serious classification, Class I, which indicates that use of the recalled devices may cause serious injury or death.
July 8, 2021
Philips released an update to a global supplemental clinical information document that contained results based on its own testing of the affected devices, stating that: “According to analysis performed by Philips, the majority of particulates are of a size (>8 μm) . . . Smaller particulates (<1-3 μm) are capable of diffusing into deep lung tissue.”
June 14, 2021
In a separate communication, the company advised physicians that the recalled devices “could result in a wide range of potential patient impact, from transient potential injuries, symptoms and complications, as well as possibly serious injury which can be life-threatening or cause permanent impairment.”
June 14, 2021
Philips announced a world-wide recall of millions of its CPAP, BiPAP, and mechanical ventilator machines because of the potential health risks of defective PE-PUR foam in the devices. Royal Philips has directly overseen and managed the recall.
May 17, 2021
Ken Cole from RJ Lee, an industrial forensics analytical laboratory and scientific consulting firm, produced a presentation analyzing the foam in Philips’s Trilogy EVO devices, “prompted by staff observation of color variance across both current production and previous builds.”
April 26, 2021
Philips warned investors in its first quarter earnings report of “possible risks to users” of breathing assistance machines but did not disclose the full extent of its knowledge about the risks posed by the PE-PUR foam and attempted to deflect the blame on factors. At no point prior to this date did Philips even hint that there was a dangerous condition in its recalled devices.
April 13, 2021
Two months prior to the recall, Philips launched the DreamStation 2, which does not contain PE-PUR sound abatement foam.