Phillips is recalling certain c-pap machines

The US Food and Drug Administration (FDA) has those ventilators, BiPAP and CPAP devices by using Philips Respironics , and their healthcare providers suggest that Philips Respironics certain devices (see table below) has recalled due to possible health risks.

Polyester-based sound-absorbing polyurethane foam (PE-PUR), which is used to reduce noise and vibration in these affected devices, can break and possibly enter the airways of the device. In this case, the person using the device may inhale or swallow the black residue from the foam or certain chemicals that enter the airways of the device.

If you use any of these affected devices, speak to your doctor to decide the appropriate treatment for your condition and follow the FDA recommendations listed below.

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021. Please see the Philips Respironics recall notice for more information

Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30 and BiPAP A30 / A40 device models

BIPAP AND CPAP MACHINES:

FANS:
All devices manufactured before April 26, 2021, all serial numbers
Continuous fan: Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimal Ventilation Support, Home Use: A-Series BiPAP Hybrid A30 (not sold in the US) A-Series BiPAP V30 Auto
Continuous ventilator, no life: Series A BiPAP A40 Series A BiPAP A30

BiPap or CPAP: Recommendations for affected BiPAP or CPAP users and carers

• Talk to your doctor to decide the right treatment for your condition, which may include:
  • Stop using your device
  • Please use another similar device that is not part of the callback.
  • Use alternative treatments for sleep apnea, such as positional therapy or oral appliances that fit like a sports mouthguard or orthodontic retainer.
  • Begin long-term therapies for sleep apnea, such as Consider weight loss, avoidance of alcohol, smoking cessation, or surgical options for moderate to severe sleep apnea.
  • Continue to use your affected device if your doctor determines that the benefits outweigh the risks mentioned in the recall notice.
• Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Ozone cleaners can make foam breakdown worse, and there are other potential hazards associated with using ozone products and ultraviolet (UV) light to clean CPAP machines and accessories .
• Register your devices on the Philips Respironics product recall website. Notice non- liability for external links to stay informed of Philips Respironics updates for new instructions or other patches required by the FDA.
• Report any problems with a device using the FDA MedWatch Voluntary Reporting Form.

Ventilators: Recommendations for those using affected home ventilators and caregivers

• Do not stop or change the use of the ventilator without talking to your doctor.
  • Other ventilation options for treatment may not exist or may be very limited for patients requiring a ventilator for life support therapy or in cases where discontinuation of therapy is unacceptable. In these situations, and in the judgment of the treating clinical team, the benefits of continued use of these ventilators may outweigh the potential risks identified in the recall notice.
• Talk to your doctor about using an in-line bacterial filter that can help filter out foam particles, as described in the Philips recall notice. Currently, the FDA has no evidence of the safety and effectiveness of any filter in reducing the risk of foam, and the FDA review is ongoing. It is important to keep the following considerations in mind:
  • Filters do not help reduce exposure to certain chemicals that can be released from PE-PUR foam.
  • Filters can affect fan performance by increasing the resistance to airflow through the device.
  • After inserting the filter, you should pay close attention to any build-up of foam residue on the filter or resistance problems in the air hoses.
• Register your devices on the Philips Respironics product recall website external link Warning .
• Report any problems with a device using the FDA MedWatch Voluntary Reporting Form.

Recommendations for healthcare providers and institutions

• Follow the recommendations above for affected devices used in healthcare facilities.
• Review the recommendations above with patients using the affected devices.
• Repair affected equipment and check for signs of foam breakdown.
  • If there are signs of foam degradation, such as If, for example, black residue appears on the device, discontinue use of the device if possible and report any problems with a device using the FDA MedWatch Voluntary Reporting Form.

Device description
These devices are used for breathing support. Specifically:

• A two-stage positive pressure device (also known as BiPAP , BiLevel PAP, or BPAP ) pumps compressed air through the airways of the lungs. BiPAP devices have higher pressures when you inhale and lower pressures when you exhale.
• A CPAP (Continuous Positive Airway Pressure) machine keeps the airway open by delivering a continuous flow of air through a mask. CPAP machines are devices prescribed to people with obstructive sleep apnea to help keep their airways open while they sleep.
• A continuous ventilation device is intended to mechanically control or support the patient's breathing by adding a predetermined proportion of oxygen to the breathing gas.

PE-PUR foam can be inhaled or swallowed and poses a potential health risk.
Polyester-based polyurethane (PE-PUR) is a sound-absorbing foam that is used to reduce noise and vibration in these devices and other medical devices. PE-PUR foam in affected CPAP, BiPAP and ventilation devices from Philips Respironics can:

• They disintegrate (disintegrate) into particles that get into the air circulation of the device and can be inhaled or swallowed by the user.
• Release certain chemicals into the device's airway that can be inhaled.

These issues can cause serious, life-threatening injury, cause permanent deterioration, and require medical intervention to prevent permanent damage.
To date, Philips Respironics has received several complaints regarding the presence of black particles or particles in the airway of the device. Philips Respironics has also received reports of headache, upper respiratory tract irritation, cough, chest pressure, and sinus infections that may be related to this problem, although the cause of the symptoms may not be clearly related.

Possible risks of particle exposure are irritation of the skin, eyes and airways, an inflammatory reaction, headache, asthma and toxic or carcinogenic effects on organs such as the kidneys and liver.

Potential risks of exposure to chemicals released into the device's airways from PE-PUR foam include headache; Dizziness; Irritation to eyes, nose, respiratory tract and skin; Hypersensitivity; Nausea vomiting; and toxic and carcinogenic effects.

Foam degradation can be exacerbated by high temperature, high humidity environments and the use of unauthorized cleaning methods such as ozone.

To date, no deaths have been reported as a result of these issues.

FDA measures
The FDA is working with Philips Respironics to assess the problem, the scope of the recall, and the most appropriate containment strategies, including the company's corrective actions.

The FDA is reviewing Medical Device Reports (MDRs) related to affected devices during the 2009-2021 period for reports that may relate to this issue.

The FDA currently has no indications that other CPAP devices, BiPAP devices or ventilators from Philips or other manufacturers are affected.

The FDA will continue to monitor supply and demand to assess the availability of affected devices and potential bottlenecks.

The FDA will continue to provide updates to the public as we learn more.

Report problems with your device
If you think a problem with a CPAP, BiPAP or mechanical ventilator to have had , recommends the FDA to report the problem via the voluntary reporting form from MedWatch .

Medical personnel employed in facilities subject to FDA user facility reporting must follow the reporting procedures established by their facility.

Ask?
For more information on recall notification, please contact your local Philips representative or visit the Philips Respironics recall notification website external link Warning .

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