Medical DevicesRespironics Issues North American Recall Of SmartMonitor(R)2 Infant Apnea Monitor
Respironics announced today that it has voluntarily recalled 4,992 infant apnea monitors. This recall of the SmartMonitor®2 models 4002 and 4003 is being conducted due to the possibility of an audible alarm failure. Caregivers or parents who are using a SmartMonitor 2 Infant Apnea Monitor for their infant, should contact their homecare provider immediately to determine if their device is affected. However, they should continue using the apnea monitor until it is replaced, unless directed otherwise by a physician.
The SmartMonitor 2 Infant Apnea Monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.
If the device fails to alarm during an apnea or heart rate event, the device will not deliver an audible alert to direct the caregiver to respond to the patient. There is a possibility that the lack of response by a caregiver to an apnea or heart rate event may result in serious injury or death. Even 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 United States and Canada. Respironics provided notification of the recall to distributors and user providers, sales personnel and customers by letter and phone beginning on April 27, 2009. The firm is continuing to contact customers to arrange for the return of all the recalled apnea monitors.
Respironics has received one report of an alarm failure; however no injury resulted. Respironics has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Homecare 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 http://www.fda.gov/medwatch.
U.S. Food & Drug Administration