Respironics, the manufacturer of the SmartMonitor 2 Infant Apnea Monitor, announced that it has voluntarily recalled 4,992 infant apnea monitors. The device continuously monitors infant respiration and heart rate in the hospital or in the infant's home or in the hospital. The monitor was designed to detect, and sound an alarm for, periods of temporary interruption of breathing (central apnea) or low heart rates. The FDA announced that the Class 1 recall is necessary to protect consumers from serious injury.

Class 1 is the most serious degree of recall, involving a reasonable probability that use of affected products will cause serious injury or death.

This recall applies to SmartMonitor 2 models 4002 and 4003 -- caregivers and/or parents 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.

Any adverse reactions experienced with the use of this device 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.

Labels: Adverse Events, Class 1 recall, devices, FDA, MedWatch, SmartMonitor

On Monday, May 18, the FDA issued a class I recall for SmartMonitor 2 Infant Apnea Monitor. A class I recall is the highest recall level that can be issued and is only issued when a product has a reasonable probability of causing serious injury or death. The recalled Apnea monitor is manufactured by Respironics, a Pennsylvania based health care device manufacturer.

The SmartMonitor 2 is used by both hospitals and consumers alike. It is used as a monitoring device in order to continuously watch an infant’s breathing and heart rate. The recall was issued because the SmartMonitor2 can fail to alarm when an infant’s breathing stops or his/her heart rate drops to a dangerously low level. The models that are being recalled were manufactured between January 16, 2008 and November 13, 2008. They were distributed from January 13, 2008 to December 31, 2008. The model numbers being recalled include model 4002 and 4003. The serial numbers of the recalled models are 3000033364 through 3000038740. The FDA advises that all stop using the product immediately and to report any problems to their doctor and the FDA. Currently, there have been no recorded fatalities from this device.

More than 4,900 defective infant apnea monitors have been voluntarily recalled. The potential defect is the failure of the audible alarm, which may cause the alarm not to sound when it should. The FDA stated that on April 23, 2009 Respironics notified medical supply companies of the potential defect in the SmartMonitor 2 infant apnea monitors. Respironics wanted all monitors in the companies’ inventories retuned.
Customers with questions or concerns regarding the SmartMonitor2 infant apnea monitor recall may contact Respironics at 1-888-345-4630.The FDA requests that Health care professionals and consumers may report adverse reactions or quality problems related to the recalled infant apnea monitors to the FDA's MedWatch Adverse Event Reporting program via:
Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
FAX: 1-800-FDA-0178

For more information please see: http://www.fda.gov/MedWatch/safety/2009/safety09.htm#SmartMonitor
http://www.fda.gov/cdrh/recalls/recall-042309.html

Labels: apnea, children, devices, FDA, monitor, recall