Philips Respironics Archives - Page 2 of 3

How Philips’ significant respiratory devices recall unfolded

There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s how the Philips Respironics recall got to this point.

Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could potentially degrade and get into the airways.

Fast forward a year and a half, and Philips is still effectively out of the respiratory devices market as it works to repair the devices. FDA presently has 90,000 reports of problems — including 260 mentioning deaths.

Philips CEO Roy Jakobs has said the Dutch medtech giant is deeply sorry about the recall.

Meanwhile, competitor ResMed has struggled amid supply chain challenges to fill the resulting CPAP shortage. ResMed CEO Mick Farrell said this week that patients in some parts of the world have to wait up to 12 weeks to receive a CPAP after a sleep apnea diag…

Philips says recalled DreamStation sleep therapy device tests show ‘unlikely’ harm to health

The DreamStation CPAP machine. [Image from Philips’ website]Philips (NYSE:PHG) today issued an update following tests on health risks related to its recalled DreamStation sleep therapy devices.

Amsterdam-based Philips’ testing showed that, among other things, exposure to certain emissions from the recalled devices is “unlikely to result in appreciable harm to health in patients.”

The update marks the latest development in the long recall saga surrounding the company’s Philips Respironics subsidiary.

Last year, Philips stopped taking orders of sleep therapy systems as it handled a Class I recall of certain devices. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines.

It attributed the recall to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a dev…

More deaths reported in Philips respiratory devices recall

The FDA announced today that it has received more than 90,000 reports of problems — including 260 mentioning deaths — in Philips’ massive respiratory devices recall.

It’s important to note that FDA’s Medical Device Reporting (MDR) system is a passive system with limitations. Still, today’s update from the FDA is but another reminder of the seriousness of the Philips recall. The previous update in late summer listed 69,000 MDR entries since April 2021, including 168 reports of death.

New Philips CEO Roy Jakobs publicly apologized for the Philips Respironics recalls last month. The recalls involve 5.5 million CPAP and BiPAP ventilators and other respiratory devices.

In addition to consent decree talks with the DOJ and FDA, Philips also faces lawsuits.

The recall involves potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway. The p…

New Philips CEO says he is ‘deeply sorry’ over Respironics recall

Roy Jakobs is slated to become Philips’ president and CEO, effective October 15. [Image courtesy of Royal Philips]Royal Philips’ new CEO Roy Jakobs has apologized for the company’s ongoing massive Respironics recalls.

Since April 2021, the FDA has received more than 69,000 medical device reports, including 168 reports of death, related to sound abatement foam breaking down in CPAP and BiPAP ventilators and other respiratory devices. (Note: The FDA’s MDR system is a passive system with limitations.)

In a recent statement to stakeholders, Jakobs recognized the serious recalls, which involve millions of devices. He said the Dutch medtech giant is taking steps to realign itself with its “people-centered” ideology.

“Delivering on this is what matters most, and that will require us to double down on what we do best, continuing to innovate, but also urgently fixing things where we have disappointed patients and customers. …

Philips Respironics CPAP, BiPAP mask recall is Class I

[Image from FDA]The FDA today issued a notice confirming that a recall of Philips (NYSE:PHG) Respironics face masks is Class I, the most serious kind.

Last month, Philips provided an update on an issue with its CPAP and BiPap masks. The Respironics subsidiary alerted users of CPAP or BiPAP therapy masks with magnetic headgear clips or straps. The devices could negatively interact with implantable, metallic medical devices.

Respironics has distributed more than 17 million masks containing magnetic clips. As of Aug. 30, the company received 14 reports suggesting that the maks may have impacted implanted devices. The affected masks include the Amara View full face mask, the DreamWisp nasal mask, the DreamWear full face mask, the Wisp and Wisp Youth nasal mask and the Therapy Mask 3100 NC/SP.

According to the FDA, Philips recalled nearly 18.7 million units in the U.S. since initiating the recall on Aug. 2. It distributed the devices between Jan. 1, 2015, and Se…

Another Philips respiratory devices recall receives a Class I label

The FDA announced today that it is labeling another Philips Respironics recall as Class I, its most serious classification.

The new recall involves 386 ventilators distributed from Aug. 6, 2020, to Sept. 1, 2021. The BiPAP machines may contain plastic in their motors that could release volatile organic compounds (VOCs). On top of the risk of users inhaling dangerous VOCs, the plastic could also cause device failure.

At this time, the FDA is not aware of any reports of serious injury or death. The BiPAP machines can treat both adults and children at home and in clinical environments, including hospitals and sleep laboratories.

Mounting troubles for Philips Respironics

The latest serious recall comes as Philips continues to grapple with a deadly recall that involves more than a million CPAPs, ventilators and other respiratory devices. Problems stem from polyester-based polyurethane sound abatement foam that could break down. Foam particles could enter a de…

Philips Respironics issues updated instructions on CPAP, BiPAP masks

The Philips Amara View full face mask. It is one of the masks affected by the company warning.

Philips (NYSE:PHG) announced that its Respironics subsidiary warned users of certain therapy masks of potential issues with implanted devices.

The company alerted users of certain CPAP or BiPAP therapy masks with magnetic headgear clips or straps. Such devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body.

Philips said the magnetic headgear clips attach headgear straps to the masks. The company noted that this is a “commonly used” method in the sleep therapy devices industry.

This represents the latest addition to the mounting troubles for Philips Respironics. The company has been dealing with a massive recall of CPAP and BiPAP ventilators and other respiratory devices and has been in talks with federal p…

Philips Respironics has a new serious recall for certain ventilators

Philips (NYSE:PHG) has a new FDA Class I recall for its ventilators, adding to recall issues that have plagued the company for a year.

The FDA issued a notice alerting patients, caregivers and providers that certain Philips Respironics bi-level positive airway pressure (BiPAP or BPAP) machines may contain a plastic contaminated with a non-compatible material. If such plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). It may also cause the machine to fail and stop working suddenly during use.

FDA said the potential risks of inhaling VOCs include headaches, dizziness, irritation in the eyes, nose, respiratory tract and skin, hypersensitivity reactions, nausea or vomiting and toxic and cancer-causing effects. If the plastic causes the machine to fail and stop working suddenly, it may lead to serious injury or death.

At this stage, the FDA is not aware of any reports of serious injury or deat…

FDA says 44 more deaths have been reported in Philips ventilator recall

The FDA issued an update to its communication on Philips Respironics’ ventilator recall confirming the reports of 44 more deaths.

Last year, Amsterdam-based Philips (NYSE:PHG) Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

At the time, the company stopped taking orders of sleep therapy systems as it handled the Class I recall. In March of this year, the FDA told Philips that its notification efforts on the recall of its ventilators had been inadequate to that point.

In April, the company revealed a Department of Justice subpoena for information related to the recall of its respiratory devices. …

ResMed names Lucile Blaise as new Sleep & Respiratory Care leader

Lucile Blaise will become president of ResMed’s Sleep & Respiratory Care business on July 1. [Photo courtesy of ResMed]

Lucile Blaise will be the new president of ResMed’s Sleep & Respiratory Care business starting July 1, ResMed (NYSE: RMD) said today.

She replaces Jim Hollingshead, who became president and CEO of Insulet (Nasdaq:PODD) on June 1. ResMed President and COO Rob Douglas is serving as interim president of the Sleep & Respiratory Care during the transition.

Blaise is ResMed’s VP of Sleep & Respiratory Care for Western Europe. She joined San Diego-based ResMed in 2006 and has more than 25 years of experience in medical device sales, marketing, finance, and business development, the company said in a news release.

Blaise serves on the MedTech Europe board and was elected president of French medtech association Snitem this month.

ResMed CEO Mick Farrell …

Philips updates on testing results for recalled ventilators

Royal Philips (NYSE:PHG) today provided an update on the test and research program implemented after its major ventilator recall.

In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

Philips said last year that it wasn’t taking orders for sleep therapy systems as it dealt with the Class I recall that knocked it out of the market for a year. In March, the FDA issued a notification order alerting Philips that its notification efforts on the recall of its ventilators had been inadequate to that point.

In April, the Amsterdam-based company revealed a Department of Justice subpoena f…

FDA says Philips ventilator recall produced over 21,000 device reports, 124 deaths

The FDA updated its communications on Philips‘ (NYSE:PHG) major ventilator recall with new data on device reports and patient deaths.

In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

According to the FDA’s notice, the agency received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown in Philips Respironics’ ventilator devices between April 2021 and April 30, 2022.

Within the MDRs received by FDA — both mandatory reports from Philips and voluntary reports from health…