Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Mechanical ventilation devices: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent 200, BiPAP V30, BiPAP A30/Hybrid/A40
- Serial Numbers: Devices manufactured before April 26, 2021, all serial numbers
- Distribution Dates: November 5, 2005 to April 23, 2021
- Devices Recalled in the U.S.: 204,776
- Date Initiated by Firm: June 14, 2021
These devices are used to provide breathing assistance. Specifically:
- A continuous ventilator device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- A bilevel positive airway pressure (also known as BiPAP, BiLevel PAP, or BPAP) machine pumps air under pressure into the airway of the lungs. BiPAP machines have a higher pressure when you breathe in and lower pressure when you breathe out.
Reason for Recall
Philips Respironics, Inc., recalled certain ventilators and BiPAP devices due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam that is used in Philips Continuous and Non-Continuous Ventilators, i.e., PE-PUR foam may break down into small pieces that may enter the device’s air pathway and then be swallowed or inhaled when the device is used. Additionally, the PE-PUR foam may release (off-gas) certain chemicals.
The off-gassed chemicals and foam particles may lead to serious or life-threatening injuries, difficulty breathing (respiratory distress), swelling (inflammation), a lack of oxygen (hypoxia), too much carbon dioxide (hypercarbia), or toxic reactions.
There have been 83 complaints, no injuries, and no deaths reported for these issues.
Who May be Affected
- Health care providers using affected Philips Respironics mechanical ventilators or BiPAP devices
- Caregivers of patients using affected Philips Respironics mechanical ventilators or BiPAP devices
- Patients who require care using affected Philips Respironics mechanical ventilators or BiPAP devices
What to Do
On June 14, 2021, Philips sent customers an “Urgent: Medical Device Recall” letter to customers that included some immediate actions:
For mechanical ventilators:
- Do not stop or alter prescribed therapy until talking to care providers. Alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
- If the physician determines that use must continue, use an inline bacterial filter, using Instructions for Use to guide installation.
The company asked all customers to register device(s) on the company’s recall website. The website also offers:
- Current information on the recall status
- How to receive permanent corrective action to address the issues
- Instructions on how to locate the device Serial Number
- Guides users through the registration process.
The FDA also recommends:
For People Who Use Affected Ventilators At Home and Caregivers
- Do not stop or change ventilator use until you have talked to your health care provider. Alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and in the judgment of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification.
- Talk to your health care provider about using an inline bacterial filter, which may help to filter out particles of foam, as indicated in the Philips recall notification. At this time, the FDA does not have evidence of the safety and effectiveness of a filter for mitigating the foam risks, and the FDA’s evaluation is ongoing. It is important to note the following considerations:
- Filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam.
- Filters may affect ventilator performance because they may increase resistance of air flow through the device.
- Closely monitor for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter placement.
For Health Care Providers and Facilities
- Follow the recommendations above for the affected devices used in health care settings.
- Review the recommendations above with patients who use the affected devices.
- Service affected devices and evaluate for any evidence of foam degradation.
- If there is evidence of foam degradation, such as black debris in the device, stop use of the device, if possible, and report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.
Customers with questions about this recall should contact Philips’ recall support hotline at 1-877-907-7508, or visit the website at www.philips.com/src-update.
- Medical Device Recall Database Entry
- Urgent Medical Device Recall Notice
- FDA Safety Communication: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.