Philips updates vent instructions
By HME News Staff
Updated 9:37 AM CST, Mon November 25, 2024
WASHINGTON – Philips has updated its instructions for using Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin EVO and LifeVent EVO2 due to risk of inaccurate flow measurements caused by certain in-line nebulizer placements, according to the U.S. Food and Drug Administration. The company says to be aware that this issue may affect any device that has ever been used with in-line nebulizer treatments. The updated instructions include making sure all alarms are set appropriately and keeping alternate ventilation sources available in case the ventilator stops working or doesn’t work properly. Philips also provided images of acceptable in-line nebulizer placements. The company had previously provided instructions on Oct. 7. Philips is updating use instructions 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. Impacted flow sensors may cause inaccurate flow measurements, leading to patients inadvertently experiencing too much air (tidal) flow or not enough oxygen without awareness of the ventilator operator. This may cause serious adverse health consequences, including respiratory discomfort, lung damage (volutrauma/barotrauma) from over-delivery of tidal volume, low oxygen saturation and/or shortness of breath (dyspnea) from therapy delays or under-delivery of oxygen and death. There have been four reported injuries. FMI: https://www.fda.gov/medical-devices/medical-device-recalls/ventilator-correction-philips-updates-use-instructions-trilogy-evo-evoo2-ev300-evo-universal-aeris.
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