Wingspan may present unacceptable risks, such as stroke and death, to many patients previously considered appropriate for treatment with Wingspan.

Ventilator power supply failure may lead to unexpected cessation of ventilation and failure of alarm to sound.

Potential error code may cause a delay in patient therapy or result in serious injury and/or death to the patient.

If a patient with a known or unknown allergy/sensitivity to chlorhexidine or silver sulfadiazine/sulfa drug is exposed to this product, there is the potential for an allergic reaction.