Sentec/Percussionaire Recalls Ventilator Valve

Sentec/Percussionaire is recalling (Class 1 device correction) its Phasitron 5 In-Line Valve to update use instructions due to an increase in reports of patient injuries after users failed to remove the blue plug from the expiratory port when applying therapy directly to a patient’s airway. “Failure to remove this cap during direct airway therapy can lead to the patient receiving too much pressure from the ventilator,” a recall notice says. “The use of affected product without following updated instructions may cause serious adverse health consequences, including heart attack (cardiac arrest), air entering the space between the lung and the chest wall (pneumothorax), an airway (tracheobronchial) tear and death.” To date, there have been six reported injuries.

 The intrapulmonary percussive ventilation device is part of the company’s Phasitron 5 system that provides therapy to patients who are receiving mechanical ventilation to help them breathe, according to the notice.