Philips Respironics has issued a voluntary correction for its Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators and the usage of in-line nebulizers.
In an Oct. 7 news announcement, Respironics said, “An Urgent Medical Device Correction (Field Safety Notice in the rest of world) is being sent to health systems and equipment distributors and is being communicated through this additional 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 health-care provider. This update, and the associated Urgent Medical Device Correction (Field Safety Notice in the rest of world), provides instructions for user action and guidance for continued use of affected devices. Philips Respironics is investigating a solution and will provide additional information when available.”
Aerosol deposits from in-line nebulizers could form on ventilator flow sensors
The announcement described an in-line nebulizer as “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,” the announcement said. “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.”
Respironics said that if aerosol deposits accumulate on the flow sensor, the ventilator could become inoperative after stand by or powering off, which could delay patient therapy. Over-delivery of inhaled and exhaled air and/or under-delivery of oxygen for devices with a specific concentration setting could also occur.
“Potential hazards to patients from these conditions may include respiratory discomfort; lung injury from too much air in the lungs or change in pressure (volutrauma/barotrauma); low oxygen saturation; or shortness of breath (dyspnea),” the announcement said.
Patients using the Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, or Trilogy EV300, as well as home medical equipment suppliers, can read the Philips Respironics announcement for specific equipment recommendations, as well as customer service phone numbers.
