Philips Respironics Recalls Certain Reworked Philips Respironics Trilogy 100/200 and Garbin Ventilators Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris
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.
- Product Name: Philips Respironics Trilogy 100, Trilogy 200, and Garbin Plus ventilators
- Product Models and Serial Numbers: See recall database entries
- Distribution Dates: March 1, 2022, to September 6, 2022
- Devices Recalled in the U.S.: 13,811
- Date Initiated by Firm: December 7, 2022
Note: This recall is for certain reworked ventilators that were also recalled in June 2021. BiPAP and CPAP machines reworked or replaced due to the recall in June 2021 are not affected by this new recall. Adhesive is not used to hold the silicone foam in place in the reworked or replaced BiPAP and CPAP machines.
Philips Respironics (Philips) Trilogy and Garbin ventilators are used to provide breathing assistance to both pediatric and adult patients. A ventilator is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen. Trilogy and Garbin ventilators are intended to be used in homes and health care settings, including when patients may be using a wheelchair or gurney.
Reason for Recall
Philips is recalling certain reworked Philips Trilogy 100, Trilogy 200, and Garbin Plus ventilators for two recent issues:
- The silicone sound abatement foam installed to replace PE-PUR foam may separate from the plastic backing due to adhesive failure. The silicone foam material may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. If an alarm is not recognized or acted upon, the patient could experience trouble breathing, such as asphyxia, hypoventilation, or hypoxemia, which can be life threatening.
- Philips observed residual PE‐PUR sound abatement foam in some reworked ventilators that were returned to customers. Further exposure to PE-PUR foam may cause potential health risks, which can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users.
As of January 4, 2023, there have been 82 MDRs (63 MDRs for foam delamination and 19 MDRs for particulate debris contamination) and no deaths.
Who May be Affected
- People who receive breathing support from the affected Phillips Trilogy 100, Trilogy 200, or Garbin Plus ventilators.
- Health care providers and in-home caregivers who provide care for patients who receive breathing support from the affected Phillips Trilogy 100, Trilogy 200, or Garbin Plus ventilators.
What to Do
Phillips sent affected customers an Urgent Medical Device Recall letter in December 2022. The letter offered the following recommendations for device owners and health care providers.
Devices in use
- Ensure the clinical assessment of the patient is up to date and reflects true acuity and respiratory therapy requirements. Patients may experience serious harm if a device malfunctions and immediate intervention is not available.
- Adhere to the below instructions until Philips can correct this problem.
- For ventilator dependent patients
- Consider transitioning to an alternative life-support ventilator if, as determined by the clinical assessment for the individual patient in consultation with the patient’s health care provider, a malfunction would lead to serious injury if timely access to a backup ventilator is not possible.
- Quarantine all impacted devices that are removed from service.
- Indicate which serial numbers must be removed from service in exchange for an alternative device.
- For all other patients
- Ensure that device alarm settings are configured appropriately for your patient’s needs, with special consideration for the alarms listed below.
- Ensure that alternative ventilation equipment is available, as appropriate to patient need, in case of emergency issues with alarms that cannot be resolved.
- Ensure that backup monitoring is configured as required by the clinical assessment. Pulse oximetry, ECG, heart rate, blood pressure, or respiratory rate may provide additional advanced warning of and lead to faster intervention if hypoxemia were to occur. If these accessories are prescribed, ensure patients are advised of proper use.
- Consider using an inline bacterial filter which may help filter out particles of PE-PUR foam. It is important to note the following considerations:
- Filters may affect ventilator performance because they may increase resistance of airflow through the device.
- Closely monitor for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter replacement.
- Consult your Instructions for Use for guidance on installation.
- If alarms occur, caregivers or health care providers must investigate the source of the alarm. If the situation cannot be resolved, then the ventilator must be exchanged for a back-up ventilator. The following alarms could trigger if the silicone foam separates from airpath:
- Low Inspiratory Pressure
- Low Minute Volume
- High Temperature
- Check Circuit
- Low Circuit Leak
Devices not in use
- Immediately quarantine any affected reworked Trilogy 100 and Trilogy 200 devices that are not currently on patients and await further instructions from Philips for returning this inventory.
- Indicate which serial numbers have been quarantined when responding to the company’s letter.
Philips is offering Trilogy Evo devices on loan (as supply is available) for patients who must be transitioned due to the acuity of their care until there is a more permanent corrective action process in place.
The FDA issued a safety communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris, for health care providers, patients, and their caregivers.
For further information or support concerning this issue, please contact your local Philips representative or Philips Customer Service at 1-800-345-6443 or visit Philips Information for Patients.
- Medical Device Recall Database Entries
- Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris
- FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls
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 the online form or call 1-800-332-1088 for more information on how to mail or fax the form.