Philips Respironics, affiliated to Dutch consumer electronics giant, announced additional usage instructions for Trilogy Evo Ventilators related to use of in-line nebulizers.
The company has issued an urgent medical device correction in the United States for Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators regarding the use of in-line nebulizers. In the rest of the world, a field safety notice has been given.
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.
According to the company, the use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. If this happens, there is a possibility of inaccurate flow measurements affecting therapy.
However, Philips Respironics has not received any specific complaints of device malfunctions resulting from in-line nebulizer use so far, and no patient deaths have been reported.
Meanwhile, Trilogy Evo ventilators that have never been used with in-line nebulizers are not affected by the issue and can continue to be used as guided.
As part of ongoing quality management, the company performed a retrospective review and identified a potential issue with flow sensors.
If aerosol deposits accumulate over time on the flow sensor, there is a possibility of patient impact as the ventilator may become inoperative following stand by or powering off, leading to delay in therapy. It could also result in over-delivery of inhaled and exhaled air and/or under-delivery of oxygen for devices with a specific concentration setting.
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, as well as shortness of breath (dyspnea).
The urgent medical device correction is being sent to health systems and equipment distributors, so that patients who use the devices at home will receive the information on time.
Further, the company urged the patients not to discontinue therapy without consulting their healthcare provider.
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