SMART MONITOR 2

Additional Manufacturer Narrative

AT THIS TIME, THERE IS NO EVIDENCE THAT THE MONITOR CAUSED OR CONTRIBUTED TO THE REPORTED FIRE AND RESULTANT CAREGIVER INJURY. CIRCADIANCE IS SEEKING AN OUTSIDE EXPERT TO FURTHER ANALYZE THE MONITOR TO EITHER CORROBORATE OR ALTER THE CONCLUSIONS DERIVED FROM OUR INTERNAL ANALYSIS. GIVEN THAT A DOCUMENTED CAREGIVER INJURY WAS REPORTED, CIRCADIANCE HAS CHOSEN TO FILE AN MDR REPORT WITH THE FDA EVEN THOUGH THERE IS NO INDICATION THAT THE MONITOR MALFUNCTIONED AND/OR CAUSED OR CONTRIBUTED TO REPORTED CAREGIVER'S INJURY.

Description of Event or Problem

(B)(6) CONTACTED CIRCADIANCE TO REPORT THAT A SMART MONITOR 2 INFANT APNEA MONITOR AND AN OXYGEN CYLINDER HAD BEEN INVOLVED IN A "FLASH FIRE". THE FOLLOWING TEXT IS COPIED FROM THE SUBMISSION FORM RECEIVED FROM (B)(6): "THIS DEVISE (SIC) WAS USED AT THE SAME TIME AN OXYGEN TANK EMITTED A FLASH FIRE. THE MOTHERS (SIC) FOOT WAS BURNED NO INJURY TO THE CHILD OR ANYONE ELSE. THE APNEA MONITOR CONTINUED TO WORK WITHOUT INTERRUPTION. PLEASE DO A FULL INVESTIGATION OF EQUIPMENT WITH A DETAILED REPORT OF THE FUNCTIONALITY OF APNEA MONITOR." A FOLLOW UP CALL TO (B)(6) REVEALED THAT THE PATIENT'S MOTHER EXPERIENCED A SECOND DEGREE BURN ON HER FOOT AND REQUIRED TREATMENT AT A HOSPITAL. CIRCADIANCE IS NOT AWARE OF WHETHER OR NOT THE MOTHER WAS ADMITTED TO THE HOSPITAL OR IF TREATMENT WAS ADMINISTERED IN THE EMERGENCY DEPARTMENT. THERE IS NO REPORTED INJURY TO THE INFANT PATIENT AS A RESULT OF THIS EVENT.