CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER ASSOCIATED WITH A SMART MONITOR 2 DEVICE. THE REPORT ALLEGES THE "UNIT SHUT DOWN DURING EXAM." THE DEVICE WAS REPORTEDLY IN USE AT THE TIME OF THE REPORTED EVENT. HOWEVER, NO RESULTING EFFECT ON THE PATIENT HAS BEEN REPORTED. MULTIPLE ATTEMPTS TO REACH THE DME FOR ADDITIONAL INFORMATION AND TO HAVE THE DEVICE RETURNED FOR EVALUATION HAVE BEEN MADE. THIS INVESTIGATION IS BEING CONDUCTED DUE TO THE FACT THAT IT IS UNK WHETHER OR NOT THE DEVICE ALARMED APPROPRIATELY TO NOTIFY A CAREGIVER OF A POTENTIAL ISSUE AT THE TIME OF THE REPORTED EVENT.
N
Patient 1
(B)(4). THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVALUATION. THE SMART/MONITOR 2 (SM2) IS INTENDED FOR USE IN CONTINUOUS MONITORING OF HEART RATE AND RESPIRATION OF INFANT PATIENTS IN A HOME, HOSPITAL, OR PORTABLE ENVIRONMENT. THE SM2 RECEIVES PHYSIOLOGICAL SIGNALS VIA TRANSDUCERS ATTACHED TO THE PATIENT AND DIRECTLY CONNECTED TO THE MONITOR, OR FROM DEVICES CONNECTED TO THE AUXILIARY INPUTS OF THE MONITOR. PHYSIOLOGICAL SIGNALS (PATIENT EVENTS) AND EQUIPMENT EVENTS ARE RECORDED IN NONVOLATILE MEMORY FOR SUBSEQUENT REVIEW AND ANALYSIS BY A HEALTH CARE PROFESSIONAL. DURING MONITORING, WHEN THE PATIENT'S BREATHING EFFORT AND HEART ACTIVITY ARE NOT WITHIN THE SET BOUNDARIES, AN INDICATOR LIGHT COMES ON AND AN ALARM SOUNDS. THE POWER SOURCE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT IS UNK. HOWEVER, IF THE DEVICE WAS BEING OPERATED ON BATTERY POWER THE DEVICE IS DESIGNED TO ALARM TO NOTIFY A CARE GIVER OF THE FOLLOWING SCENARIOS: LOW BATTER WARING BATTER VOLTAGE LOW, POWER SUPPLY REQUIRED PROMPTLY. LOW BATTER SHUTDOWN BATTERY VOLTAGE TOO LOW TO CONTINUE WITHOUT POWER SUPPLY. ALTHOUGH THE CUSTOMER COMPLAINT ALLEGATION COULD NOT BE SUBSTANTIATED, MULTIPLE METHODS OF RISK MANAGEMENT HAVE BEEN INCORPORATED INTO THE DESIGN OF THE PRODUCT THAT WOULD NOTIFY A CAREGIVER OF A POTENTIAL PATIENT AND/OR PRODUCT ISSUE. CHMV HAS NO REASON TO BELIEVE THAT THE DEVICE DID NO PERFORM TO SPECIFICATION TO NOTIFY A CAREGIVER OF A POTENTIAL EVENT. QUALITY ASSURANCE HAS CONCLUDED THAT NO ADDITIONAL INVESTIGATION INTO THE REPORTED ISSUE IS APPROPRIATE AT THIS TIME, HOWEVER, IF THE DEVICE IN QUESTION IS RETURNED FOR INVESTIGATION AND IT IS CONCLUDED THAT A FAILURE OUTSIDE OF THE DESIGN SPECIFICATIONS TOOK PLACE, A FOLLOW-UP WILL BE FILED.