[18514076]
A durable medical equipment (dme) supplier contacted the manufacturer reporting an alleged event in which a caregiver reported finding her infant apneic and cyanotic with no audible alarm from the apnea monitor in use on the infant. The caregiver reported stimulating the infant to breathe. There was no report of cardiopulmonary resuscitation (cpr) being performed, further intervention, or hospitalization. The dme stated the incident occurred "sometime in the middle of the night" on (b)(6) 2010. The specific time of the event is unknown. The manufacturer received the apnea monitor for evaluation. The allegation that the monitor did not alarm could not be confirmed. The apnea monitor was visually examined and tested by the manufacturer using a simulator in accordance with the smart monitor 2 checkout procedure manual (pn 1020818). The apnea monitor detected and alarmed appropriately for simulated events and passed all required testing. The apnea monitor's memory data was downloaded and analyzed by trained associates. The downloaded memory revealed the apnea monitor was turned on at 9:49:57 pm on (b)(6) 2010 and was in use for over three (3) hours. There were no patient events recorded during that time period. The memory data also showed the apnea monitor recorded twelve (12) equipment events starting at 1:43:31 am on (b)(6) 2010 when the dme representative came to the home to pick up the monitor. The data from the apnea monitor's download indicates the monitor was in use in the home from (b)(6) 2010. There were four (4) patient events recorded on (b)(6) 2010 and seven (7) patient events recorded on (b)(6) 2010. All recorded events were associated with audible and visual alarms. There were no patient events recorded on (b)(6) 2010, the date of the reported adverse event. The dme stated that a checkout procedure was performed at the customer's home prior to the monitor being placed into use on the infant and the device passed all required testing at that time. The smartmonitor 2 was set up with a 16 second delay before recording apneas and a 20 second delay before annunciating and recording an alarm for an apnea condition. Based on the monitor data downloaded from the device, neither of these conditions was met on the date of the alleged adverse event. The smartmonitor 2 was programmed with parameters that were appropriate for recording and alarming for respiration. The smartmonitor 2 device is not intended to be used to monitor patients for cyanosis and has no capability to do so. The smartmonitor 2 parent's guide (pn 572-4000-00) states in the indications for use: "the smartmonitor 2 is intended for use in continuous monitor of heart rate and respiration of infant patients in a home, hospital or portable environment. Its primary function is detection of central apnea. Its secondary function is measurement of heart rate. The smartmonitor 2 device is not intended to prevent loss of breathing or heart activity. The smartmonitor 2 parent's guide (pn 572-4000-00) further states: the smartmonitor 2 is a monitoring device only. It does not prevent the loss of breathing or heart activity, nor will it restore breathing or heart activity. It will not prevent death. Anyone using the smartmonitor 2 to monitor an infant should be trained in current infant cardiopulmonary resuscitation (cpr), which is a proper way to restore breathing and heart activity. " there was no report of permanent harm or injury, and the manufacturer was not able to confirm the allegation of alarm failure during a patient event. The download from the smartmonitor 2 indicated that no events outside of the set parameters had occurred on the date of the alleged adverse event. The monitor passed all required testing and detected and alarmed appropriately for simulated events. Based on all available information, the manufacturer concludes that the device does not function to specification and that no further action is appropriate.
Patient Sequence No: 1, Text Type: D, B5