Philips Respironics has updated use instructions for three bi-level positive airway pressure machines, according to a recall statement posted by the US FDA.
The recall does not include removal of the devices from the market; instead, it provides instructions for correcting the devices in the event of interruptions in or loss of therapy.
The updated use instructions apply to the Philips Respironics’ BiPAP A30, BiPAP A40, and BiPAP V30 Auto, all lots, according to the statement.
The company is issuing updated instructions because of the risk for potential failure in the ventilator inoperative alarm. This failure can cause interruption or loss of therapy and has been associated with 13 injuries and 8 deaths.
The devices are designed to provide noninvasive breathing support for adults an