Timeline Stories
September 12, 2018
A report on additional testing conducted for Philips found that the PE-PUR foam showed “clear disintegration after 2 weeks.” Philips initiated “no further design change, corrective action, or field correction” of the recalled devices for at least three years. Philips continued to manufacture and sell the recalled devices.
August 24, 2018
Internal company emails show Philips personnel discussing testing showing that PE-PUR foam would break down in high heat and humidity environments, concurring with the Trilogy ventilator complaints.
June 20, 2018
Philips closed the informal CAPA investigation without reference to other CPAP and BiPAP devices that utilized the same type of foam. According to the FDA, the company implemented a “preventative maintenance procedure for Trilogy devices” but they “did not verify the effectiveness of this measure.”
May 4, 2018
Lawler wrote to Marsh, “We would not recommend using polyester foam in such an environment and have no direct data to use to calculate the rate of hydrolysis. Polyether foam lifetime would not be expected to reduce significantly at the stated conditions. Use with pure oxygen could shorten the lifetime some by promoting more rapid oxidation. I do not know the extent of the reduction, but do not expect it to be overly significant.”
May 2, 2018
In another email to Lawler, Marsh said Philips “tested [poly]ether vs [poly]ester in high heat and humidity and found ether to be the better performer.”
April 23, 2018
Marsh (Polytech) sent an email to Lawler (Burnett), confirming that Philips is “finding degradation of the ester foam and the urethane film in their device, such that particles are breaking off and flowing in the airstream.”
April 20, 2018
Philips Project Mechanical Engineer Vince Testa sent an email to PolyTech about the breakdown of PE-PUR foam that “is pulled into the ventilator air path.”
April 12, 2018
Philips opened an informal Corrective and Preventive Action (CAPA) investigation into potential foam degradation on Trilogy ventilators in Australia..
September 1, 2016
Royal Philips issued a press release regarding its promotion of the DreamStation CPAP, one of the Recalled Devices, at an international trade show. It directed media and others interested in obtaining further information to Netherlands-based Elena Calamo Specchia, who at the time, was working in Royal Philips’s Amsterdam office as the Royal Philips Spokesperson and Director of the Royal Philips Group Press Office.
August 2016
Polytech technical director Bob Marsh asked original foam manufacturer William T. Burnett technical director Lee Lawler about Philips’s request. Lawler responded, "I would not be surprised if ester foam, continuously exposed to 40C (104F) at high humidity, would exhibit signs of hydrolysis in as short a time as a year.” He said hot and humid conditions are "not a good environment for polyester foam. Polyether foam could last years in that environment.”