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…

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FDA may order Philips to resolve respiratory devices recall

The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices.

FDA’s proposal regards the June 2021 recall of millions of certain Philips 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.

Get the full story at our sister site, MassDevice.

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FDA may order Philips to resolve respiratory devices recall

The FDA proposed that an order should be issued to require Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices.

FDA’s proposal regards the June 2021 recall 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.

Amsterdam-based Philips said last summer that it was no longer taking orders of sleep therapy systems as it handled the Class I recall, which knocked it out of the sleep therapy market for at least a year. In March, the FDA issued a notification order alerting Philips that its notification efforts on the recall of its ventilators have been inadequate to date.

Last week, the company disclosed a Department…

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DOJ subpoenas Philips over Respironics recall; CEO addresses investigation

Royal Philips CEO Frans van Houten [Photo courtesy of Philips]Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpoena for information related to the massive recall of Respironics respiratory devices.

Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial and operating results. Phillips said its subsidiaries are cooperating with investigators.

“At this time, it’s a subpoena for information,” CEO Frans van Houten said on today’s earnings call. “That means they are preparing an investigation, and we just have to accept that.”

Philips shares dropped about 12% in trading Monday as the company detailed continued supply chain struggles and mounting recall costs.

Van Houten said Phillips remains in close collaboration and contact with regulatory agencies.

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DOJ subpoenas Philips over Respironics recall; CEO addresses investigation

Royal Philips CEO Frans van Houten [Photo courtesy of Philips]

Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpeona for information related to the massive recall of Respironics respiratory devices.

Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial and operating results. Phillips said its subsidiaries are cooperating with investigators.

“At this time it’s a subpeoena for information,” CEO Frans van Houten said on today’s earnings call. “That means they are preparing an investigation and we just have to accept that.”

Philips shares dropped about 12% in trading Monday as the company detailed continued supply chain struggles and mounting recall costs.<…

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Philips shares take a dive as supply chain issues, ventilator recalls impact Q1 results

Royal Philips (NYSE:PHG) shares took a hit today on first-quarter results that felt the effects of ongoing issues with supply chain and recalls.

PHG shares were down 12.1% at $26.67 in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was virtually even on the day.

The Amsterdam-based company posted losses of $161.8 million (€151 million), or 18¢ (€0.17) per share, on sales of $4.2 billion (€3.9 billion) for the three months ended March 31, 2022, for a bottom-line slide into the red on sales growth of 2.4%.

Adjusted to exclude one-time items, earnings per share came in at 16¢ (€0.15).

Philips CEO Frans van Houten said in a news release that the company’s results came in “challenging circumstances” with significant supply chain headwinds and the consequences of its ongoing issues with ventilator recalls.

Additionally, van Houten said th…

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Philips has another round of serious ventilator recalls

Royal Philips’ (NYSE:PHG) ventilator problems continue as the company has issued further recalls for its respiratory devices.

The Amsterdam-based company earlier this week issued FDA Class I recalls — the most serious kind — for all models of the Philips Respironics V60 ventilator, the V60 Plus ventilator and the V680 ventilator (distributed outside the U.S.).

For all three ventilators, an issue has been identified surrounding an internal electrical circuit within the devices. In some cases, the issue impacting the circuit could potentially result in the ventilator ceasing to operate. At least 99,283 devices are affected, with no total device number listed for the V680. The company projects an average of less than one silent shutdown with the affected devices among one million uses per year, according to a spokesperson.

Philips is not advising customers to remove the affected ventilators from service as they may continue to be used in accordance wi…

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FDA orders Philips Respironics to improve communications over ventilator recall

The FDA issued a notification order alerting Philips (NYSE:PHG) that its notification efforts on the recall of its ventilators have been inadequate to date.

On June 24, 2021, Philips Respironics recalled certain ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines due to polyester-based polyurethane (PE-PUR) sound abatement foam breaking down, allowing for the potential for the foam to enter a device’s air pathway, causing a range of potential health problems and toxic carcinogenic effects for the user.

Philips said last summer that it was no longer taking orders of sleep therapy systems as it handled the recall, which knocked it out of the sleep therapy market for at least year. The FDA classified the company’s recall of the DreamStation continuous positive airway pressure (CPAP) devices as Class I, the most serious kind, in July 2021 as a result of the foam issue.

In a news release, the FDA confi…

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FDA says Philips knew about toxic foam for years before massive recall

The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices.

The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway, causing health problems for users.

In the Form 483, FDA alerted management at the Royal Philips (NYSE:PHG) subsidiary of conditions that the inspector considered possible violations of the U.S. Food, Drug and Cosmetic Act or related regulations. The post-inspection report is not a determination of wrongdoing and will be considered by the FDA along with any evidence or documents collected from the facility and responses offered by Philips.

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FDA says Philips knew about toxic foam for years before massive recall

The FDA said it observed potential violations of federal medical device safety rules when inspecting a Philips Respironics manufacturing facility connected to the Class I recall of more than 15 million respiratory devices.

The FDA recently requested additional safety testing on replacement materials and issued a Form 483. The form details how Philips and its foam supplier were aware for years that polyester-based polyurethane (PE-PUR) sound abatement foam could break down and potentially enter a device’s air pathway, causing health problems for users.

In the Form 483, FDA alerted management at the Royal Philips (NYSE:PHG) subsidiary of conditions that the inspector considered possible violations of the U.S. Food, Drug and Cosmetic Act or related regulations. The post-inspection report is not a determination of wrongdoing and will be considered by the FDA along with any evidence or documents collected from the facility and responses offered by Philips. (Le…

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FDA requests safety testing of replacement foam in Philips sleep devices recall

The FDA said it has requested additional safety testing on the material used to repair Royal Philips (NYSE:PHG) sleep therapy devices recalled for foam that could harm patients using them.

The Class I recall that started in June covers more than 15 million devices, after hundreds of complaints and more than 100 injuries from polyester-based polyurethane (PE-PUR) sound abatement foam that broke down, allowing foam and chemicals to potentially enter the device’s air pathway and cause health problems for users.

On Friday, the FDA said that upon inspection of a Philips Respironics manufacturing facility used to make replacement foam for the recalled devices, it learned that the silicone-based product failed a safety test for the release of volatile organic compounds (VOCs). That test was conducted on a similar device sold outside the U.S.

Get the full story at our sister site, Medical Design & Outsourcing.

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FDA requests safety testing of replacement foam in Philips sleep devices recall

The FDA said it has requested additional safety testing on the material used to repair Royal Philips (NYSE:PHG) sleep therapy devices recalled for foam that could harm patients using them.

The Class I recall that started in June covers more than 15 million devices, after hundreds of complaints and more than 100 injuries from polyester-based polyurethane (PE-PUR) sound abatement foam that broke down, allowing foam and chemicals to potentially enter the device’s air pathway and cause health problems for users.

On Friday, the FDA said that upon inspection of a Philips Respironics manufacturing facility used to make replacement foam for the recalled devices, it learned that the silicon-based product failed a safety test for the release of volatile organic compounds (VOCs). That test was conducted on a similar device sold outside the U.S.

“The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and rep…

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