The SmartMonitor 2 Infant Apnea Monitor is intended for use in the continuous monitoring of heart rate and of respiration of infant patients in a hospital or home environment. The monitor detects and alarms for periods of central apnea and low or high heart rates.
If the device fails to alarm during an heart rate event or apnea, the device wouldn’t be able to deliver an audible alert to direct the caregiver to respond to the patient. There is a possibility that due to the lack of response by a caregiver to an apnea or heart rate event can result in serious injury or death. Even though if the audible alarm fails, the unit will still trigger a visual alert (red lights will come on).
The infant apnea monitors affected by this recall have been distributed in the US and Canada. The company provided notification of the recall to distributors and sales personnel, user providers and customers by letter and phone beginning on April 27, 2009. The company is continuing to contact customers to arrange for the return of all the recalled apnea monitors.
The company has received one report of an alarm failure; however no injury resulted. The company has notified the US FDA of its decision to voluntarily recall the affected product.
