SMART MONITOR 2
Received May 4, 2018
Report 3006182632-2018-00010 · MDR key 7486197
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
2 MO
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AS OF THE DATE OF THIS INVESTIGATION, CIRCADIANCE HAS NOT BEEN ABLE TO DETERMINE THE MEDICAL REASON FOR THE PATIENT "TURNING BLUE". AS SUCH, CIRCADIANCE HAS DECIDED TO CLASSIFY THIS EVENT AS A REPORTABLE EVENT TO THE FDA EVEN THOUGH THERE IS NO EVIDENCE THAT THE MONITOR IN QUESTION WAS MALFUNCTIONING AS WE ARE NOT ABLE TO DETERMINE IF THE REPORTED "FAILURE TO ALARM" WAS IN FACT RELATED TO THE MONITOR OR A PATIENT CONDITION THAT IS NOT DETECTABLE BY THE MONITOR SUCH AS AN AIRWAY OBSTRUCTION.
Description of Event or Problem
INFANT WAS REPORTED TO HAVE BEEN MONITORED BY THE DEVICE IN QUESTION. THE PARENTS REPORTED TO THE DURABLE MEDICAL EQUIPMENT PROVIDER THAT THE BABY WAS FOUND BLUE AND THE MONITOR WAS NOT ALARMING. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. THERE WAS NO PERMANENT INJURY REPORTED TO CIRCADIANCE AND THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED BACK HOME THE DAY AFTER ADMISSION.