FDA reports 124 sleep device deaths – NBC Bay Area

The company, which is at the center of a global recall of sleep aids that has left many sleep apnea patients unstable, is now under scrutiny by federal investigators on several fronts.

The Food and Drug Administration (FDA) announced that it has received more than 100 reports of deaths related to the popular medical sleep method that many around the world rely on.

The latest revelation comes after the company behind the recalled product — Philips Respironics, a subsidiary of Royal Philips — recently told shareholders that it had received subpoenas from the US Department of Justice, as part of a search.

WHY PHILIPS RESPIRONICS CALL HARDWARE?

Philips’ voluntary worldwide recall of CPAP devices, BiPAP devices, and ventilators was first announced about a year ago, in June 2021, after the company said there was carcinogenic noise-reducing foam inside the device that could break down and inhaled by its user without he-she knowing.

The Food and Drug Administration was quick to name the first recall category: a designation intended for the most serious type of recall.

FDA investigators later reported that the recall affected more than 15 million devices worldwide.

So many sleep apnea patients around the world were so dependent on the devices covered by the recall that Philips said it didn’t have enough parts to repair or replace the devices right away, leaving some patients without much choice.

Patients like Edward Coleman, a 73-year-old Vietnam veteran from Michigan, Indiana, said his VA doctors prescribed Philips DreamStation for obstructive sleep apnea, which regulates his breathing while he sleeps.

“My sleep is interrupted, you know, two to three times a night,” Edward explained. “So it’s hard to get a good night’s rest.”

Coleman said he’s still waiting for a replacement device, and since he heard about the recall, he’s now sleeping without any sleep aids after a risk assessment, but he’s worried about other veterans who may not know about the problem.

“I want to connect with other veterans so they can get the information they need to repair or replace their devices,” Coleman told NBC 5 Responds. “This is my biggest concern right now.”

Coleman’s frustration, like that of many Americans, has not been eased by the recent revelations about the regulators.

How many reports has the FDA received on medical devices?

Since April 2021, the FDA has said it has received “more than 21,000 Medical Device Reports (MDRs)” related to Philips Respironics CPAP and BiPAP anti-noise foam fractionation and ventilators.

Those reports include 124 deaths linked to Philips devices that have been recalled, according to the Food and Drug Administration.

MDRs are an after-market monitoring tool used by the US Food and Drug Administration to monitor medical devices, including reports of device malfunctions, injuries, or deaths.

An FDA spokesperson said these MDRs to the FDA include both mandatory reporting by Philips and voluntary reporting by healthcare professionals, consumers and patients.

The FDA told NBC 5 Responds that it is studying each of the reports, but felt it was important to share the initial findings with the public.

An FDA spokesperson said: “We evaluate each report and communicate this preliminary information to the public. Based on reports only, there is no direct causal relationship between deaths and foam rupture.” “The 124 deaths were not verified other than medical device reports submitted to the Food and Drug Administration.”

In response to the FDA’s findings, Philips told NBC 5 Responds that while the company is “investigating all allegations of device malfunction, death, or serious injury … the cause of the event cannot usually be determined by the monitoring system alone.” “. [de la FDA] MDR”.

A Philips Respironics spokesperson said: “Philips Respironics has received a sharp increase in complaints allegedly related to potential deterioration of the foam” after the company announced its recall in June 2021.

“Philips regrets any inconvenience this issue has caused and we are committed to supporting the patient community who rely on our sleep and respiratory solutions,” the company said.

The company also referred to a study published last December by the American Journal of Respiratory and Critical Care Medicine (AJRCCM), which found that patients who use its devices do not have an increased risk of developing cancer.

The company said: “Separated from Philips Respironics, in December 2021, an analysis was published in [AJRCCM] which did not find an increased risk of developing cancer among OSA patients who used a Philips Respironics PAP device compared to OSA patients who used a PAP device from other manufacturers, or OSA patients without treatment.”

NBC 5 Responds contacted AJRCCM to verify study details, but did not receive a response by the deadline.

Court summons and Ministry of Justice cases

Philips is starting to feel the pressure to roll back.

In a call with shareholders last month, Royal Philips CEO Frans van Houten said that on April 8, the US Department of Justice submitted a subpoena to the company and its subsidiaries in connection with the investigation. Constant recall of the product.

Van Houten said the Justice Department’s subpoena was “to provide information regarding the events that led to Respironics’ withdrawal.” Relevant subsidiaries cooperate with the agency.

The CEO added that the summons did not raise any specific accusations, but was merely a general request for information about the summons.

Pressure is also mounting in courts across the country.

In the same call, the company acknowledged that it currently faces 185 personal injury lawsuits and more than 100 class-action lawsuits related to device recalls. The company said these class-action lawsuits are expected to be combined in two cases this summer.

NBC 5 Responde reported in December that, according to an FDA examination, nearly a decade ago, the company received more than a hundred complaints about defects in its sleep aid, but it did not act immediately.

In an earlier statement, the company downplayed the FDA’s findings, saying that the “limited complaints” it had received were “evaluated and addressed” on a case-by-case basis.

Since announcing the recall, Philips said it plans to repair or replace all affected devices, but this will take some time.

To date, out of more than 15 million devices worldwide, the company has shipped 1.1 million replacement devices and repair tools to patients across the United States.

On an earnings call in April, CEO Van Houten said he expects to have 90% of replacement devices shipped to customers by 2022.

The full list of Philips devices for respiratory systems affected, according to the Food and Drug Administration:

CPAP and BiPAP devices

Device type Model name and number (all serial numbers)
Continuous breathing apparatus, minimal respiratory support, used in facilities E30 (Emergency Use Permission)
Continuous ventilator, without life support DreamStation ASV, DreamStation ST – AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T, AVAPS, OmniLab Advanced +
non-continuous fan SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto

fans

To register your affected device with Philips, and for more information on choosing and receiving a replacement device, click here.

Device type Model name and number (all serial numbers)
continuous fan Triple 100, Triple 200, Garbin Plus, Aeris, LifeVent
Continuous breathing apparatus, minimal respiratory support, used in facilities A-Series BiPAP Hybrid A30 (not marketed in the US), A-Series BiPAP V30 Auto
Continuous ventilator, without life support A Series BiPAP A40, A Series BiPAP A30

This article was originally published in English by Lisa Parker and Tom Jones for NBC. For more on NBC, go here.

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