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WHAT CAN HAPPEN TO PEOPLE WHO USE THE CPAP MACHINES?Philips’ recall notice said potential risks of particulate exposure ...
01/23/2023

WHAT CAN HAPPEN TO PEOPLE WHO USE THE CPAP MACHINES?
Philips’ recall notice said potential risks of particulate exposure associated with the foam include headache, irritation, inflammation, respiratory issues and cancer.
Reported injuries submitted to the FDA include cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.

“CLASS I” RECALL OF CPAP MACHINES - WHAT THIS MEANS?The FDA classified the June 2021 Philips recall of certain ventilato...
12/10/2022

“CLASS I” RECALL OF CPAP MACHINES - WHAT THIS MEANS?

The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Source: https://www.fda.gov/medical-devices

WHY PHILIPS VOLUNTARILY RECALLED THEIR CPAP MACHINESPhilips Respironics (Philips) voluntarily recalled certain ventilato...
12/03/2022

WHY PHILIPS VOLUNTARILY RECALLED THEIR CPAP MACHINES

Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.

Source: https://www.fda.gov/medical-devices

WHAT THE FDA SAY ABOUT PRIORITIZING REPLACEMENT DEVICESThe FDA recommended, and Philips has agreed, to implement a prior...
11/27/2022

WHAT THE FDA SAY ABOUT PRIORITIZING REPLACEMENT DEVICES

The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible.

Source: https://www.fda.gov

WHAT THE FDA IS DOING ABOUT THE PROBLEM WITH CPAP MACHINESThe FDA say they are committed to assuring that Philips takes ...
11/20/2022

WHAT THE FDA IS DOING ABOUT THE PROBLEM WITH CPAP MACHINES

The FDA say they are committed to assuring that Philips takes appropriate steps to correct the product, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement.
They have committed to keep the public informed as more information becomes available.

Source: https://www.fda.gov

HOW SERIOUS IS THE CPAP RECALL?The U.S. Food and Drug Administration classified the recall as Class I, which is the most...
11/14/2022

HOW SERIOUS IS THE CPAP RECALL?

The U.S. Food and Drug Administration classified the recall as Class I, which is the most serious and indicates the recalled devices could cause serious injuries or death.

Manufacturers such as Phillips are required to complete medical device reports for the FDA when there is information that suggests a device may have caused or contributed to a death or serious injury. Between 2011 and April 2021, Philips submitted 30 reports. Between April 2021 and April 2022, the FDA received 21,000 reports, including 124 reports of fatalities, all associated with foam breakdown.
The reports came from Philips as well as health professionals, consumers and patients.
If your device is one of the devices subject to the recall, you should stop using it immediately.

Source: https://www.forbes.com

THE PROBLEM WITH PE-PUR FOAM FOUND IN CPAP DEVICESPE-PUR Foam May Be Inhaled or Swallowed, Presenting a Potential Health...
11/07/2022

THE PROBLEM WITH PE-PUR FOAM FOUND IN CPAP DEVICES

PE-PUR Foam May Be Inhaled or Swallowed, Presenting a Potential Health Risk

Polyester-based polyurethane (PE-PUR) is a sound abatement foam used to reduce sound and vibration in these devices and other medical equipment. The PE-PUR foam in the affected Philips Respironics CPAP, BiPAP, and ventilator devices may:

-Break down (degrade) into particles which may enter the device’s air pathway and be inhaled or swallowed by the user

-Release certain chemicals into the device’s air pathway, which may be inhaled.

These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.

To date, Philips Respironics has received several complaints about the presence of black debris/particles within the device’s air pathway. Philips Respironics also has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue, though the cause of the symptoms cannot be definitively linked.

The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver.

The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.

The foam degradation may be exacerbated by high heat and high humidity environments, and by use of unapproved cleaning methods, such as ozone.
To date, there have been no reports of death as a result of these issues.

Source: fda.gov

RECOMMENDATIONS FOR PEOPLE WHO USE AFFECTED BIPAP OR CPAP MACHINESTalk to your health care provider to decide on a suita...
11/01/2022

RECOMMENDATIONS FOR PEOPLE WHO USE AFFECTED BIPAP OR CPAP MACHINES

Talk to your health care provider to decide on a suitable treatment for your condition, which may include:

-Stopping use of your device.

-Using another similar device that is not part of the recall.

-Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.

-Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.

-Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.

Source: fda.gov

CAPAP DEVICES THAT ARE BEING RECALLEDPhilips Respironics is recalling the following affected devices manufactured betwee...
10/26/2022

CAPAP DEVICES THAT ARE BEING RECALLED

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021.

CPAP and BiPAP Devices
Device Type
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
-E30

Continuous Ventilator, Non-life Supporting
-DreamStation ASV
-DreamStation ST, AVAPS
-SystemOne ASV4
-C-Series ASV
-C-Series S/T and AVAPS
-OmniLab Advanced+

Noncontinuous Ventilator
-SystemOne (Q-Series)
-DreamStation
-DreamStation Go
-Dorma 400
-Dorma 500
-REMstar SE Auto

Source: fda.gov

WHY IS THERE A PHILIPS CPAP RECALL?Philips recalled its CPAP, BiPAP and ventilator devices in June 2021 because of poten...
10/20/2022

WHY IS THERE A PHILIPS CPAP RECALL?

Philips recalled its CPAP, BiPAP and ventilator devices in June 2021 because of potential health risks. The health risks come from sound abatement foam used to keep the machines quiet and reduce vibration.

In July 2021, the FDA classified the Philips CPAP recall as a Class I recall. This means the recalled product may cause serious injury or death. Source: fda.gov

The foam may degrade and release particles and toxic gases into the machine’s airways that users may inhale or swallow. Lab tests showed degraded foam and gases contain several toxic and cancer-causing chemicals. Devices that are more than three years old or exposed to high heat or humid environments are more likely to have degraded foam.
The CPAP maker said people who inhale or ingest foam particles or gases may suffer from toxic, carcinogenic and respiratory effects.

On June 28, 2022, Philips provided an update on its PE-PUR sound abatement foam testing. The company said it doesn’t anticipate the level of chemical emissions to cause health problems.
The company also said cleaning CPAP machines with ozone cleaners resulted in those machines being 14 times more likely to have foam degradation that is visually ascertainable from a gross inspection. However, Philips has not provided any evidence that degradation can occur only in the presence of ozone. Research is ongoing and no guidance has changed.
Which CPAP Machines Were Recalled?
The recall doesn’t affect all of Philips’ breathing devices. About 80% of the affected devices are CPAP machines and about 20% are ventilators, Philips spokesman Steve Klink told Reuters.
Most of the devices come from Philips’ DreamStation line. The recall affects all serial numbers of the following affected devices manufactured between 2009 and April 26, 2021. More than half of the affected devices are in the U.S., according to Philips.

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