Summary: Philips Respironics has issued a voluntary correction for several Trilogy Evo ventilators concerning the use of in-line nebulizers. The correction warns of potential aerosol deposits accumulating on ventilator flow sensors, which could lead to inaccurate therapy delivery and potential patient harm. While no specific complaints or patient deaths have been reported, Philips has provided instructions for users and healthcare providers on how to manage the affected devices safely, including monitoring oxygen levels and ensuring backup ventilators are available.
Three Key Takeaways:
- Voluntary Correction Issued: Philips Respironics has released an urgent medical device correction for Trilogy Evo ventilators used with in-line nebulizers due to the risk of aerosol deposits affecting flow sensors.
- Potential Patient Impact: Accumulated aerosol deposits could lead to inaccurate air delivery, posing risks such as respiratory discomfort, lung injury, or low oxygen levels.
- Safety Measures Recommended: Users are advised to monitor oxygen saturation, ensure appropriate alarm settings, and have backup ventilators ready in case of malfunction.
Philips Respironics issued a voluntary correction for Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators regarding the use of in-line nebulizers.
An in-line nebulizer is a commonly used accessory that converts therapeutic liquids (such as medication/saline solutions) into an aerosol to treat different respiratory symptoms. Philips Respironics has determined that, in some circumstances, the use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy.
Trilogy Evo ventilators that have never been used with in-line nebulizers are not affected by this issue and can continue to be used in accordance with the guidance in the field safety notice.
An Urgent Medical Device Correction is being sent to health systems and equipment distributors and is being communicated through an online update to ensure patients who use the devices at home are informed in a timely manner.
Patients will receive communication from their usual health provider and should not discontinue therapy without consulting their healthcare provider, according to Phililps Respironics’ update. The update and the associated Urgent Medical Device Correction provides instructions for user action and guidance for continued use of affected devices. Philips Respironics notes that it is investigating a solution and will provide additional information when available.
Philips Respironics has not received any specific complaints of device malfunctions resulting from in-line nebulizer use. The company performed a retrospective review and identified a potential issue with flow sensors. At the time of this notification, no patient deaths have been reported.
Potential Patient Impacts
As indicated in the Urgent Medical Device Correction, if aerosol deposits accumulate over time on the flow sensor, there is a possibility of patient impact due to one or more of the following conditions: the ventilator may become inoperative following stand by or powering off, leading to delay in therapy; and over-delivery of inhaled and exhaled air (tidal volume) and/or under-delivery of oxygen for devices with a specific concentration setting (FiO2).
Potential hazards to patients from these conditions may include: respiratory discomfort; lung injury from too much air in the lungs or change in pressure; low oxygen saturation; or shortness of breath.
Customer/User Immediate Actions Required
All Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 users, regardless of in-line nebulizer use are advised to take the following steps from the device Instructions for Use:
- Ensure that specific alarms are set appropriately for patients.
- Ensure that alternate sources of ventilation are available in case a ventilator ceases to function.
If using a Trilogy Evo O2, Trilogy Evo Universal, or Trilogy EV300 device with a specific oxygen concentration (FiO2) setting:
- Ensure patients receive adequate oxygenation by continuous pulse oximetry (SpO2) monitoring in accordance with treatment protocols.
- Use an external FiO2 analyzer in specific patient cases, and switch to an alternative ventilator if an external FiO2 analyzer is not available.
- As indicated in the Instructions for use, maintain an immediately available backup device or alternative ventilator for rapid therapy transition.
If using in-line nebulizer treatments:
- Follow the visual instructions in the field safety notice for correct nebulizer placement.
- For specific prescriptions indicated in the field safety notice, transition patient to alternate device configurations.
Customers who require further information or support concerning this issue, may contact their local Philips Respironics Customer Service at:
- For DMEs and homecare customers: 1-800-345-6443, press option 4, then option 5
- For hospital customers: 1 (800) 722-9377, press option
Any adverse events experienced with the use of this product should be reported to the US Food and Drug Administration’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
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