Respironics' Recall of BiPAP Ventilator Systems Deemed Class IJul 10, 2009 | Parker Waichman LLP
A recall of BiPAP Focus Non-Invasive Ventilator Systems issued by Respironics California last September has been deemed a Class I recall by the Food & Drug Administration (FDA). Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
The recall involves BiPAP Focus Non-Invasive Ventilator System, model number PCM120PS18-2315P. This product was manufactured prior to March, 2008 and distributed from August, 2006 through April 11, 2008. The devices were distributed in the United States, Canada, Europe, Latin America, Africa and Asia Pacific.
The BiPAP Focus Non-Invasive Ventilator System is used by healthcare professionals to treat adult patients who have advanced lung disease and/or have difficulty breathing. According to the recall notice, power supply failures have occurred on some ventilators. A power surge may exceed the power supply capacity, causing the power supply to lose 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.
Respironics has received several reports of device failure; however, there have been no reports of injury.
Respironics is providing replacement power cords to customers. On September 22, 2008, the company sent a letter to their U.S. customers and distributors with the affected devices informing them of the potential problem. The letter included instructions for device removal and replacement, and return of the company’s response form.