In the 11 years leading up to its 2021 recall of more than 5 million CPAP and BiPAP machines and ventilators, Philips received thousands of complaints about the devices—and failed to turn many of them over to the FDA in the required timely manner—according to the results of a yearlong investigation by ProPublica and the Pittsburgh Post-Gazette.
Reporters analyzed more than 100,000 complaints that were submitted either to Philips or the FDA—and subsequently logged in the Manufacturer and User Facility Device Experience database, better known as MAUDE—between 2010 and this year.
They found that, despite a federal law requiring all complaints submitted to devicemakers be passed on to the government within one month, Philips sat on more than 3,700 complaints it had received about the respiratory devices between 2010 and the official start of the recall in mid-2021.
According to Wednesday’s report, more than 2,500 of those complaints were more than two years old by the time they were finally passed on to the FDA.
Philips had reportedly determined that the held-back complaints didn’t need to be submitted to the FDA, but later did so “out of an abundance of caution.” Meanwhile, the FDA told the outlets that the company had withheld “numerous complaints” that should have been passed along to the agency.
Even as the complaints streamed in over the course of a decade, it wasn’t until 2019 that Philips launched a formal investigation. Not only was that “three years after the first known tests for the company found that the foam was degrading,” per the investigation, but it also came a year after Philips reportedly recruited a group of engineers and safety supervisors for “a series of urgent meetings in Pittsburgh to investigate the problem.”
Philips didn’t alert device users to the issue for another few years after the investigation began: As it described in an update (PDF) earlier this year, “In prior years, there were limited complaints related to foam degradation, which Philips’ subsidiary Philips Respironics evaluated and addressed on a case-by-case basis. Potential concerns relating to the emission of volatile organic compounds began to surface only more recently. When Philips became aware of the issue and its potential significance in early 2021, actions were taken leading to the field safety notice in June of 2021.”
Up until that point, the company was waging “aggressive global marketing campaigns to sell more machines,” according to the reporters, who claimed that Philips “suppressed mounting evidence that its profitable breathing machines threatened the health of the people relying on them, in some cases to stay alive,” in favor of boosting its own profits.
“It was a catastrophic series of errors,” an ex-Philips compliance supervisor told the two publications. “There were people who knew and knew for a long time.”
Shortly after the recall formally began in mid-2021, the FDA handed down a Class I rating, denoting a heightened risk of injury or death associated with the recalled products. Philips has spent the time since working to repair or replace 5.5 million recalled machines; in a statement Wednesday, the company said, “The remediation of the sleep therapy devices is nearing completion, while the remediation of the affected ventilators is ongoing.”
Elsewhere in the statement, Philips argued that ProPublica and the Post-Gazette’s report “[does] not present new facts and we do not agree with the characterizations made in these articles.”
“Philips regrets any distress and concern for patients, their families and care providers in this matter, and deeply apologizes for this,” the company added. “Philips acted to protect patient safety by initiating and executing a voluntary recall notification/field safety notice of significant scale. We continue to dedicate all available resources to ensure that patients receive remediated devices.”
The complaints dating back to 2010 reportedly detailed the same issues that ultimately sparked the formal recall: The polyester-based polyurethane (PE-PUR) foam that Philips began adding to the machines around that time to muffle sound and vibrations was found to be at risk of breaking down over time, sending potentially dangerous particles and chemicals into a user’s airflow.
In notices about the recall, the FDA has warned that exposure to the debris and chemicals could cause irritation, headache, asthma, nausea and “toxic or cancer-causing effects to organs, such as kidneys and liver.”
As of the end of March, the agency has tallied a total of more than 105,000 medical device reports, including 385 reports of death—though these reports are unconfirmed and may or may not actually be linked to Philips’ devices.
Though Philips initially acknowledged the risk that the disintegrating foam could emit potentially “toxic and carcinogenic” materials, it has since pushed back on any link between the PE-PUR foam and the reported patient injuries and deaths. Recent test results published by the company claim that exposure to particles or chemicals released by the foam “is unlikely to result in an appreciable harm to health in patients.”
However, a trio of experts who reviewed the results for ProPublica and the Post-Gazette pointed out that the foam did repeatedly test positive for genotoxicity—though Philips has said those results, as with the others, fall within acceptable safety standards. Still, that particular finding is “alarming,” per the outlets’ experts, since it indicates that the particulates could damage the genetic information within a cell, potentially creating cancer-causing mutations.
“You can’t make the argument that it’s safe. That’s bad science,” said an engineer familiar with the testing. “It’s a real-life failure that shows you have a problem. There’s no ambiguity. There is unacceptable risk. Full stop.”