Description of Event or Problem · 1
A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER CONTACTED THE MANUFACTURER REPORTING AN ALLEGED EVENT IN WHICH A CAREGIVER REPORTED THE "APNEA ALARM DIDN'T SOUND/LIGHT UP DURING AN APPARENT LIFE THREATENING EVENT." THE CAREGIVER REPORTED TAKING THE INFANT TO THE HOSPITAL. THE DME STATED THE INCIDENT OCCURRED "CLOSE TO WHEN THE MONITOR WAS LAST USED". THE SPECIFIC DATE AND TIME OF THE EVENT IS UNKNOWN. THE MANUFACTURER RECEIVED THE APNEA MONITOR FOR EVALUATION AND DETERMINED THE DEVICE DID NOT MALFUNCTION. 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 RELEASED SERVICE PROCEDURES. THE TESTING PROCESS USED IN SERVICE IS THE SAME TEST SEQUENCE USED DURING THE MANUFACTURING PROCESS FOR NEW MONITORS. THE APNEA MONITOR DETECTED AND ALARMED APPROPRIATELY FOR ALL SIMULATED EVENTS GENERATED DURING THE SERVICE TEST SEQUENCE. DURING THE REPAIR EVALUATION, IT WAS DISCOVERED THE UNIT NEEDED A NEW MODEM PCA; HOWEVER, ALL CONDITIONS FOR ALARMS WERE VERIFIED TO PERFORM TO SPECIFICATIONS. THE MODEM PCA HAS NO IMPACT ON THE MONITORING CAPABILITY OF THE SMARTMONITOR 2 AND IS ONLY USED FOR REMOTE ACCESS TO THE MONITOR VIA AN ANALOG PHONE LINE. THE SMARTMONITOR 2 DEVICE IS NOT INTENDED TO PREVENT LOSS OF BREATHING OR HEART ACTIVITY. THE SMARTMONITOR 2 PARENTS' GUIDE (PN 572-4000-00) 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." THE SMARTMONITOR 2 PARENTS' GUIDE (PN 572-4000-00) FURTHER STATES IN THE WARNINGS AND CAUTIONS: "SMARTMONITOR 2 MAY NOT BE ABLE TO DETECT ALL EPISODES OF INADEQUATE BREATHING. IF A BABY HAS APNEA DUE TO CHOKING (OBSTRUCTIVE APNEA), THE MONITOR COULD MISTAKE MOVEMENT CAUSED BY CHOKING FOR BREATHING." THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY, AND THE MANUFACTURER WAS NOT ABLE TO CONFIRM THE ALLEGATION OF ALARM FAILURE DURING A PATIENT EVENT. BESIDES NORMAL SERVICING, 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 FUNCTIONED TO SPECIFICATION AND THAT NO FURTHER ACTION IS APPROPRIATE.