SMART MONITOR
Received Aug 26, 2009 · Event occurred Aug 6, 2009
Report 1472619 · MDR key 1472619
Device
Product problems
- Device Alarm System
- Function indicator light(s), failure of
Patient
29 DA
- Respiratory arrest
Narrative
Description of Event or Problem
WHILE THE MOTHER OF THE INFANT WAS FEEDING THE BABY, THE APNEA MONITOR RESPIRATION LIGHT STOPPED BLINKING AND THE HEART RATE LIGHT STARTED TO SLOW. THE BABY STOPPED BREATHING. THE BABY'S FAMILY PERFORMED CPR AND THE BABY WAS TRANSPORTED TO THE HOSPITAL FOR OBSERVATION. THE PATIENT'S FAMILY NOTED THE HEART RATE WAS GREATER THAN 200 BPM, BUT NOTED THE MONITOR DID NOT ALARM. HOWEVER, THE HIGH HEART RATE INDICATOR LIGHT WAS SHOWING RED; INDICATING THAT AN ALARM HAD OCCURRED. THE ALARM SETTINGS WERE HHR=200, LHR=80, APNEA DELAY= 20 SECONDS. THE MONITOR WAS REMOVED FROM THE HOME AND SENT TO THE MANUFACTURER FOR TESTING.INITIAL RESPONSE HAS BEEN NO PROBLEMS IDENTIFIED WITH THE MONITOR; FACILITY IS CURRENTLY AWAITING WRITTEN REPORT. THEY COULD SEE TWO EVENTS, AND ACCORDING TO THE READ OUT, THE ALARM SOUNDED BOTH TIMES.