AMSTERDAM—Philips released updated instructions for multiple ventilators, due to the risk of inaccurate flow measurements caused by in-line nebulizer placements, the Food and Drug Administration (FDA) released in a statement. The FDA said this recall—or correction—involves updating instructions for using devices, rather than removing them from where they are used or sold. The FDA identified this recall as the most serious type and said the devices may cause serious injury or death if use is continued without following the updated instructions.
Philips said it updated use instructions for its Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal, Aeris EVO, Garbin Evo and LifeVent EVO2 ventilators, due to the risk of aerosol deposits accumulating over time on the device’s internal flow sensor when in-line nebulizers are used in certain locations. Philips said the impacted flow sensors may cause inaccurate flow measurements, which can lead to patients inadvertently experiencing too much air (tidal) flow or not enough oxygen without awareness of the ventilator operator.
The FDA advised that the use of affected product may cause serious adverse health consequences, including respiratory discomfort, lung damage from over-delivery of tidal volume, low oxygen saturation and/or shortness of breath from therapy delays or under-delivery of oxygen and death. There have been four reported injuries in relation to incorrect ventilator usage.
A full list of the affected products and updated use instructions are listed below.
Affected Products
- Product Names: Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal, Aeris EVO, Garbin Evo and LifeVent EVO2.
- Model Numbers: DS2110X11B, DS2100X11B, DS2200X11B, DS2000X11B, VT2110X24B, LD2110X23B and SP2100X26B.
- Lot/Serial Numbers: All.
Philips’ Recommendations on What to Do
Be aware that this issue may affect any device that has ever been used with in-line nebulizer treatments.
Follow the updated instructions for use:
- Make sure all alarms are set appropriately.
- Keep alternate ventilations sources available, in case the ventilator stops working or doesn’t work properly.
- Follow acceptable in-line nebulizer placement circuit instructions.
If using with a set FiO2 oxygen concentration setting:
- Use continuous pulse oximetry (SpO2) monitoring according to treatment protocols.
- Make sure patients receive adequate oxygen by using an external FiO2 analyzer in specific patient cases, and switch to an alternative ventilator if an external FiO2 analyzer is not available.
- Maintain an immediately available back‐up device or alternative ventilator for rapid therapy transition (indicated in Instructions for Use).
If using in-line nebulizer treatments:
- Follow the visual instructions notice for correct nebulizer placement.
- Transition patients to alternate device configurations for specific prescriptions as outlined in the letter.
The FDA recommended durable medical equipment and home care customers in the U.S. should contact Philips with any question at 1-800-345-6443, option 4, then option 5. Additionally, hospital customers should call: 1 (800) 722-9377, option 2
