CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A REPORT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER STATING THAT A SMART MONITOR DEVICE HAD ALLEGEDLY FAILED TO ALARM FOR A LOW HEART RATE OF 34 BEATS PER MINUTE. THE MOTHER WAS REPORTEDLY FEEDING THE CHILD AT THE TIME OF THE REPORTED EVENT. THE MOTHER REPORTEDLY CALLED EMERGENCY SERVICES AND DELIVERED RESCUE BREATHS IN RESPONSE TO THE REPORTED EVENT. HOWEVER, THE MOTHER DID NOT DELIVER CHEST COMPRESSIONS. THE CHILD WAS HOSPITALIZED AND HAS REPORTEDLY SINCE RECOVERED FROM THE EVENT. NO LASTING IMPACT HAS BEEN REPORTED. FURTHER CORRESPONDENCE WITH THE DME INDICATED THAT THE MOTHER THOUGHT THAT THE UNIT WAS READING OXYGEN SATURATION LEVELS AS WELL AND THAT IS WHY THEY THOUGHT IT DID NOT ALARM APPROPRIATELY. THE EXACT DATE OF THE REPORTED EVENT IS NOT KNOWN.
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Patient 1
(B)(4). CHILDREN?S MEDICAL VENTURES (CHMV) RECEIVED THE DEVICE FOR EVAL. THE UNIT WAS FOUND TO OPERATE AND ALARM APPROPRIATELY FOR SIMULATED EVENTS. THE APNEA MONITOR?S MEMORY DATA WAS DOWNLOADED AND ANALYZED BY TRAINED ASSOCIATES. THE DOWNLOADED MEMORY REVEALED THAT THE SMART MONITOR WAS SET UP WITH PRESCRIBED SETTINGS OF A 16 SECOND DELAY BEFORE RECORDING APNEAS AND A 20 SECOND DELAY BEFORE ANNUNCIATING AN ALARM FOR AN APNEA CONDITION. NO OBSERVATIONS SUBSTANTIATING A MALFUNCTION OR OTHER OPERATION OUTSIDE OF DESIGN SPECIFICATIONS WERE MADE DURING THE EVAL. THE UNIT WAS FOUND TO OPERATE AND ALARM WITHIN SPECIFICATIONS. SMARTMONITOR 2 IS DESIGNED TO MONITOR AND RECORD PATIENT?S BREATHING (RESPIRATION), HEART (CARDIAC) ACTIVITY. THE MONITOR ALERTS YOU IF ANY OF THESE ACTIVITIES EXCEEDS THE LIMITS PRESCRIBED BY THE PHYSICIAN. PATIENT ALARM LIMITS ARE SET BY THE HEALTH CARE PROFESSIONAL BEFORE THE SMARTMONITOR 2 IS DELIVERED TO THE PATIENT. DURING MONITORING, WHEN THE PATIENT?S BREATHING EFFORT AND/OR HEART ACTIVITY ARE NOT WITHIN THESE SET BOUNDARIES, AN INDICATOR LIGHT COMES ON AND ALARM SOUNDS. THE SMARTMONITOR 2 DEVICE IS NOT INTENDED TO PREVENT LOSS OF BREATHING OR HEART ACTIVITY. THE SMARTMONITOR 2 PARENTS? GUIDE ((B)(4)) 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 USER MANUAL STATES THE FOLLOWING USER/OWNER RESPONSIBILITIES. THE RESPIRONICS MONITOR AND ACCESSORIES ARE DESIGNED TO WORK AS DESCRIBED IN THE OPERATOR?S MANUAL. THE USER(S) OF THIS EQUIPMENT SHOULD NOT USE PARTS THAT HAVE FAILED, EXHIBITED EXCESSIVE WEAR, ARE CONTAMINATED, OR OTHERWISE INEFFECTIVE. THE MONITOR AND ITS ACCESSORIES SHOULD NOT BE MODIFIED. THE FOLLOWING LIST INCORPORATES THE OWNER?S RESPONSIBILITIES: PERIODIC CHECK AND MAINTENANCE OF EQUIPMENT; REPLACEMENT OF COMPONENTS AS REQUIRED FOR SAFE AND RELIABLE OPERATION; REPLACEMENT OF INEFFECTIVE PARTS WITH PARTS SUPPLIED BY RESPIRONICS, INC; EQUIPMENT THAT IS NOT FUNCTIONING PROPERLY MUST NOT BE USED UNTIL ALL NECESSARY MAINTENANCE HAS BEEN COMPLETED AND A FACTORY AUTHORIZED SERVICE REP HAS CERTIFIED THE EQUIPMENT AS READY FOR USE; THE MONITOR AND ANY OF ITS ACCESSORIES SHOULD NOT BE MODIFIED; AS A GENERAL RULE, THE PROPER PERFORMANCE OF THE MONITOR SHOULD BE VERIFIED WITH A RESPIRONICS MODEL 5000 SIMULATOR ACCORDING TO THE CHECKOUT PROCEDURE MANUAL (B)(4) BETWEEN EACH PATIENT USE OR EVERY 6 TO 12 MONTHS OR WHICHEVER IS MORE FREQUENT. THE USER OF THIS EQUIPMENT IS RESPONSIBLE FOR READING, UNDERSTANDING, AND FOLLOWING THE WARNING AND CAUTION STATEMENTS THROUGHOUT THIS MANUAL. NO OPERATIONAL ISSUES WERE RECORDED DURING THE EVAL. THE UNIT WAS FOUND TO OPERATE TO SPECIFICATION AND DOES NOT PRESENT AN INCREASED RISK TO PATIENT SAFETY. QUALITY ASSURANCE HAS DETERMINED THAT NO FURTHER INVESTIGATION ACTIVITY IS REQUIRED.