Certain Philips Respironics BiPAP devices are being recalled due to a plastic issue: FDA Safety Communication | Panda Anku

Date of issue: August 29, 2022

The U.S. Food and Drug Administration (FDA) is warning patients, caregivers, and healthcare providers that Philips Respironics (Philips) has recalled certain dual-level positive airway pressure devices (also known as bilevel PAP, BiPAP, or BPAP) that may contain a plastic, contaminated with an incompatible material. When this plastic is in the appliance engine, it can release certain chemicals of concern known as volatile organic compounds (VOCs). The plastic can also cause the machine to fail and suddenly stop working during use.

This recall is Not related to the PE-PUR foam issue affecting certain BiPAP devices recalled in June 2021, detailed in Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. However, this new recall applies to some of the devices recalled in June 2021.

Philips distributed 386 affected BiPAP devices in the United States between August 6, 2020 and September 1, 2021. On August 26, 2022, Philips sent an urgent medical device recall letter to affected customers, including suppliers of Durable Medical Equipment (DME). The models, some of which are intended for use in clinical settings only, are listed below; However, only machines with the serial numbers listed in the company’s Urgent Medical Device Recall Letter are affected by this recall.

  • A-Series BiPAP A30 (ventilator)
  • A-Series BiPAP A40 (ventilator)
  • A-Series BiPAP V30 (automatic ventilator)
  • OmniLab Advanced+

Recommendations for patients and caregivers

  • The devices of the A series BiPAP A30 (ventilator) and the A series BiPAP A40 (ventilator). were also included recall issued by Philips Respironics in June 2021. If you have an A-Series BiPAP A30 (ventilator) or A-Series BiPAP A40 (ventilator):
    • No action is required if your device was repaired or replaced prior to the June 2021 recall as the affected plastic components were also replaced.
    • If your device was Not have already been corrected or replaced by the June 2021 recall, register your device on the Philips website if you have not already done so and speak with your doctor to decide if your care and treatment plan is changing as a result of this recall should change .
  • If you have a health issue, including those listed under Potential Health Issues below, or have a problem with your device, talk to your doctor and report the issue or issue using the MedWatch Voluntary Report Form.

Recommendations for Healthcare Providers

Locate all recalled devices in your facility.

  • The A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ devices, intended for use in clinical settings only, are Not a part of the June 2021 recall issued by Philips Respironics. Replace these devices with a non-affected device or discuss with your patient (or their caregiver, if applicable) if their care and treatment plan should change as a result of this recall.
  • The A-Series BiPAP A30 (ventilator) and A-Series BiPAP A40 (ventilator) devices, intended for use either in clinical settings or by patients at home, were also included recall issued by Philips Respironics in June 2021. For healthcare providers whose patients use an A-Series BiPAP A30 (ventilator) or A-Series BiPAP A40 (ventilator):
    • If the device has already been repaired or replaced by the June 2021 recall, no action is required as the affected plastic components have also been replaced.
    • If the device was Not has already been corrected or replaced by the June 2021 recall, if you have not already done so, register the device on the Philips website and discuss the best course of treatment with your patient.

If you are treating a patient who has a health condition, including those listed under Potential Health Issues below, or has a problem with a device, we encourage you to report any health or device problems using the MedWatch Voluntary Reporting Form.

Summary of FDA Recommendations

device Second hand Remind What to do
A-Series BiPAP A30 (ventilator)

At home or in clinical settings

From adult and pediatric patients

For obstructive sleep apnea syndrome or respiratory insufficiency

For the plastic issue in August 2022 and for the foam issue in June 2021

No action if the device was repaired or replaced as a result of the June 2021 recall as the affected plastic components were also replaced.

If the device has not already been corrected or replaced by the June 2021 recall, register the device on the Philips website if you have not already done so and speak with your doctor to decide if the plan is right for you Care and treatment should change as a result of this recall.

A-Series BiPAP A40 (ventilator)

At home or in clinical settings

From adult and pediatric patients

For obstructive sleep apnea syndrome, respiratory failure or respiratory failure

For the plastic issue in August 2022 and for the foam issue in June 2021

No action if the device was repaired or replaced as a result of the June 2021 recall as the affected plastic components were also replaced.

If the device has not already been corrected or replaced by the June 2021 recall, register the device on the Philips website if you have not already done so and speak with your doctor to decide if the plan is right for you Care and treatment should change as a result of this recall.

A-Series BiPAP V30 (automatic ventilator)

In clinical settings only

From adult and pediatric patients

For obstructive sleep apnea syndrome or respiratory insufficiency

For the August 2022 plastic edition Replace these recalled devices with non-affected devices or discuss with your patient (or their caregiver, if applicable) if their care and treatment plan should change as a result of this recall.
OmniLab Advanced+

In clinical settings only

From adult and pediatric patients

For obstructive sleep apnea syndrome or respiratory insufficiency

For the August 2022 plastic edition Replace these recalled devices with non-affected devices, or discuss with your patient (or their caregiver, if applicable) if their care and treatment plan should change as a result of this recall.

device description

A positive two-stage airway pressure machine (also known as a bilevel PAP, BiPAP, or BPAP) pumps air at varying pressures into the airways of the lungs. BiPAP machines (ventilators) use higher pressure when you breathe in and lower pressure when you breathe out. These devices are prescribed for people with obstructive sleep apnea syndrome to keep their airways open during sleep, people with respiratory failure (not enough oxygen inhaled or carbon dioxide exhaled), or respiratory failure (not breathing). BiPAP devices can be used to treat adult and pediatric patients in the home and in clinical settings such as hospitals and sleep labs, depending on the IFU for each device model.

Contaminated plastic in certain Philips BiPAP devices

The Philips Respironics BiPAP devices affected by this recall may contain a plastic that is contaminated with a non-compatible material. When this plastic is in the appliance engine, it can release certain chemicals of concern known as volatile organic compounds (VOCs). The plastic can also cause the machine to fail and suddenly stop working during use.

Potential risks of inhaling VOCs include:

  • headache
  • dizziness
  • Irritation to the eyes, nose, airways (respiratory tract) and skin
  • Hypersensitivity reaction such as B. an allergic reaction or other immune system response
  • nausea or vomiting
  • Toxic and carcinogenic effects

If the plastic causes the machine to fail and suddenly stop working, serious injury or death could result.

The FDA is not aware of any reports of serious injuries or deaths related to the recalled BiPAP devices due to the contaminated plastic issue.

FDA Actions

The FDA recognizes that patients rely on these devices, and we are closely monitoring the company’s actions to ensure issues are resolved in a timely manner. We continue to work with Philips to ensure the company takes appropriate action to correct the products.

In this recall, as with recalls in general, the FDA reviews the strategy the company is proposing to address the issue, assesses the health hazard the product poses, and determines whether the issue violates FDA laws or is a potential violation against FDA requirements, and whether to assign a classification (I, II, or III) to the recall to indicate the relative level of risk.

Although this recall is unrelated to the foam issue detailed in Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, the FDA continues to carefully review all of the devices available to it available information in determining appropriate next steps.

The FDA will keep the public informed as important new information becomes available.

Reporting problems with your BiPAP device

If you have a health issue, including those listed under Potential Health Issues, or an issue with your BiPAP device, the FDA encourages you to report the issue using the MedWatch voluntary report form.

Healthcare workers employed at facilities subject to FDA user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you require additional information or assistance regarding this issue, please contact Philips Respironics Callback Support at 1-877-387-3311 or email pms.fac@philips.com.

For more information on medical device recalls, including what is a medical device recall, visit FDA.gov.

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