SMART MONITOR 970SE
Received Feb 23, 2012 · Event occurred Jan 25, 2012
Report 3007056120-2012-00004 · MDR key 2472034
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Death
Narrative
Description of Event or Problem
A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER REPORTED THAT AN INFANT PASSED AWAY WHILE USING A SMART MONITOR 970SE INFANT APNEA DEVICE. IT WAS REPORTED THAT "THE CHILD HAD BEEN TO THE DOCTOR AND UPON RETURNING HOME WHEN THE PARENTS WENT TO TAKE THE CHILD OUT OF THE CAR, THEY NOTICED THE CHILD APPEARED LIFELESS." THE EXACT DATE OF THE PT DEATH IS NOT KNOWN AT THIS TIME AND CONFLICTING REPORTS AS TO WHETHER OR NOT THE PT WAS ON THE UNIT AT THE TIME OF THE REPORTED INCIDENT HAVE BEEN RECEIVED. THE PT DOWNLOAD AND THE DEVICE WERE RETURNED TO THE MANUFACTURER FOR EVAL. THE MANUFACTURER IS CURRENTLY INVESTIGATING THE DETAILS INTO THE REPORTED EVENT. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.