OWLET BABY CARE
Received Apr 18, 2025 · Event occurred Mar 10, 2025
Report 3012977166-2025-00001 · MDR key 21866713
Device
Generic name
Owlet Dream Sock Plus Health Notifications
Manufacturer
Owlet Baby Care, Inc.Model number
DREAM SOCK PLUS HEALTH NOTIFICATIONSProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
2 MO · Female
- Low Oxygen Saturation
- Low Oxygen Saturation
Narrative
Additional Manufacturer Narrative
NO ALLEGATIONS OF DEFICIENCY WERE MADE BY THE USER. HOWEVER, OWLET CONDUCTED A THOROUGH INVESTIGATION AND REVIEWED THE HISTORICAL DATA ANALYSIS AND BACKEND DATA. THE TIMELINE AND CORRESPONDING INTERACTION WITH THE DEVICE AND DEVICE FUNCTION ALIGN WITH THE CUSTOMER NARRATIVE AND INDICATE THAT THE DEVICE FUNCTIONED AS INTENDED IN ALERTING THE CUSTOMER TO A DESATURATION EVENT. NO DEVICE DEFICIENCY OR MALFUNCTION WAS IDENTIFIED DURING THE INVESTIGATION. THEREFORE, THE CONCLUSION OF THE INVESTIGATION IS THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED DEATH.
Description of Event or Problem
OWLET WAS CONTACTED FOR A REQUEST FOR DATA REGARDING A DESATURATION NOTIFICATION. OWLET WAS INFORMED THAT THE INFANT HAD PASSED WHILE WEARING THE OWLET DREAM SOCK.