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Inaccurate oxygen levels lead to Class I recall of over 62,800 Philips ventilators
Philips has recalled ventilators in its Trilogy EV series. (photo of the Trilogy EV300, courtesy of Philips)
Philips is facing yet another Class I recall, the most serious type, for more than 62,800 ventilators used worldwide that it says may not accurately provide the amounts of oxygen required for high-concentration therapies.
Such treatment requires the fraction of inspired oxygen (FiO2) in a ventilator to be programmed above the standard 5% maximum, but Philips says its Trilogy EV300, Trilogy Evo O2 and Trilogy Evo Universal may be delivering FiO2 levels well below programmed levels, and that the internal FiO2 sensor may inaccurately show a higher oxygen concentration. The issue is most likely to occur when FiO2 setpoints should be more than 70%.
The recall affects hospital-based devices, and not the stand-alone Trilogy EVO solution often used in home care, said the company in a letter issued to hospitals in March. The issue was discovered “as part of our intensified quality efforts, and through our internal testing of devices,” it said.
Philips plans to release a software update free of charge to affected users, who can continue to use these solutions, it says, albeit while monitoring a patient’s oxygen saturation levels. They should also use an external oxygen concentration monitor for the device during high-concentration therapy, and have a back up to quickly change oxygen delivery methods if necessary.
Its most recent recall prior to this one was in February for 1,200 unidentified first generation CPAP devices in the U.S. and France after discovering that they were programmed with either an incorrect serial number or a duplicate serial number, creating communication issues with the Care Orchestrator care management software that could cause patients to experience different pressure and comfort settings than they prefer.
“Affected devices may continue to be used in accordance with device instructions for use. At the time of this notification, Philips Respironics has not received reports of patient harm. To date, we are more than halfway with the shipments of replacement devices to patients,” said spokesman Steve Klink, head of global press office and industry analyst relations, in a statement.
