Andover, Mass., USA. - In September 2008 Respironics announced a voluntary recall of 2,270 power cords for the BiPAP Focus Ventilator System. This recall, which affects certain units manufactured prior to March 2008, was initiated to address power supply failures which occurred in the field. Respironics is providing replacement power cords to customers.

A disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in transient power surges, which may cause damage to components within the power brick and lead to a loss of power. If there is a failure of power during operation, the BiPAP Focus will switch to back up battery power, which can provide up to 50 minutes of operation on a fully charged battery at default settings. Audible and visual alarms will alert clinicians to the loss of power, so that appropriate corrective actions can be taken.

In the unlikely event that alarms do not prompt the clinical team to provide alternative respiratory support before the battery is exhausted, patients may be at risk for serious injury or death due to low levels of oxygen or high levels of carbon dioxide in the blood. These risks apply primarily to patients who cannot breathe on their own, although it should be noted that the labeling for the BiPAP Focus Ventilator specifically states it is not intended for use on such patients.

The BiPAP Focus Ventilator power cords affected by this recall have been distributed in the United States, Canada, Europe, Latin America, Africa and Asia Pacific. U.S. customers and international distributors were notified of the recall on September 22, 2008. Respironics continues to work with customers to ensure the power cords are replaced in a timely manner. Customers can easily replace the power cords.

The BiPAP Focus Ventilator provides non-invasive ventilation (e.g., for use with nasal or full face masks) for adult patients (weighing more than 30 kg or 66 lbs) for the treatment of respiratory insufficiency or obstructive sleep apnea. It is also contraindicated in patients with a lack of spontaneous respiratory drive and is not intended to be a life support device. The BiPAP Focus is appropriate for acute, sub-acute, and intra-hospital transport settings and is not intended for home use.

Respironics has received several reports of failure; however, there have been no reports of injury. Respironics has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Healthcare providers with questions may contact Respironics Customer Service at 1-877-387-3311.

Any adverse reactions experienced with the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch. Adverse reactions and/or quality problems should also be reported to Respironics at 1-800-345-6443.

Respironics is a Philips Healthcare company.

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