Royal Philips (NYSE:PHG) issued an urgent field safety notice for its V60 ventilators after issues arose surrounding unresponsive touchscreens.
In August, the Amsterdam-based company warned that the V60 ventilator’s touchscreen designed for changing certain therapy settings experienced problems with failure to respond to touch commands. The frozen screen can result in an inability to make changes without warning.
Because the device’s therapy settings can not be changed, a delay in therapy could lead to a drop in a patient’s SP02 level, resulting in hypercarbia or hypoxemia, although the device will continue to function at the settings applied prior to the malfunction, Philips said. The Philips V60 Ventilator provides noninvasive and invasive ventilatory support for spontaneously breathing adult and pediatric patients.
The company has not received any reports of patient adverse events due to the problem, according to a company spokesperson.
The company recommended that, if an alternative is not available, the patient should continue to use the ventilator even if there is touchscreen failure. Philips said it will support V60 customers by installing new touchscreens on affected ventilators at no cost to the customer.
In March 2017, Philips issued a recall for a select number of its V60 respiratory ventilators after its version 2.20 software caused the device’s blower motor to stall and the unit to shut down. It was later determined to be a Class I FDA recall.
The V60 system features both noninvasive ventilation and high flow therapy, which is designed to allow the system to be used with changing patient conditions without having to switch devices. The V60 is intended for early interventions into respiratory failure and designed to deliver a wide range of non-invasive support for patients to lessen the challenge of weaning patients off of noninvasive ventilation. It received CE Mark approval in November 2018.
