A ProPublica and Post-Gazette analysis of tens of thousands of reports shows that #Philips withheld more than 3,700 complaints over 11 years from the FDA, which oversees medical devices.

And the company did not launch a formal investigation of the problem until 2019 — nine years after the first wave of complaints and three years after the first known tests for the company found that the foam was degrading.
Instead, as the complaints continued to pile up in company files, Philips waged aggressive global marketing campaigns to sell more machines, including new models fitted with the #hazardous #foam.

The sales pitch worked:
The devices went to infants, the elderly and at least 700,000 veterans.
The company also promoted machines meant for some of the sickest people in the country, rolling out a new ventilator filled with the foam in the early months of the COVID-19 pandemic.

Philips didn’t stop even after the company learned the foam was breaking down in its ventilators in Japan and had to be replaced
— and after tests in the United States revealed that the material released chemicals at dangerous levels.
Among them: #formaldehyde, a compound used in fertilizer, dyes and glues that has been tied to respiratory problems and certain #cancers.
In 2018, the company called more than a dozen engineers and safety supervisors to a series of urgent meetings in Pittsburgh to investigate the problem in what eventually became known to insiders as "Project Uno."
Still, the public was not warned.
All the while, people using Philips machines were suffering from illnesses that no one could explain:
#vomiting, #dizziness and #headaches, along with newly diagnosed #cancers of the lungs, throat, sinuses and esophagus.
One man in Philadelphia coughed so hard that he broke his ribs, and a Florida woman with a hacking cough was hospitalized for days and placed on oxygen.
“Unconscionable,” said Dr. Radhika Breaden, who scrambled at her Oregon sleep clinic to help thousands of patients who were using the devices. “We were all completely blindsided. You can’t have people inhaling black dust … without warning us.”

Company records that show officials knew about the dangers but continued to sell machines that the FDA has since said are capable of causing severe illness or death.

Reporters also reviewed thousands of complaints submitted to the company and government describing device malfunction and injuries, including more than 370 reports of deaths.

As part of the investigation, the news organizations collaborated with Mediahuis NRC, the publisher of one of the largest newspapers in the Netherlands, where Philips’ parent company is located.

In a statement to the news organizations, Philips said its top priority is patient safety and that it regretted “the distress and concern” caused by the recall.
“We deeply apologize for that and continue to work hard to resolve this,” the company said.

Philips said complaints about the foam were limited in the years before the recall and that the reports were evaluated on a case-by-case basis.

The company added that it became aware of the potential significance of the problem in early 2021 and launched the recall shortly after that.

Former company engineers and safety supervisors, who spoke on the condition of anonymity because they still work in the industry, said top officials at Philips repeatedly dismissed a dangerous breakdown that ultimately set off a worldwide health crisis involving as many as 15 million devices.

“It was a catastrophic series of errors,” said a former compliance supervisor. “There were people who knew and knew for a long time.”

https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared