MalfunctionLBI
PHOTOTHERAPY BILIBLANKET
Received May 22, 2026 · Event occurred Mar 8, 2026
Report 25259324 · MDR key 25259324
Device
Generic name
Unit, Neonatal Phototherapy
Manufacturer
Bistos Co., Ltd.Patient
7 DA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT WAS GIVEN A BILIBLANKET FROM DME COMPANY SUPPLY FOR HOME USE. THE NEXT DAY, FAMILY REPORTED TO CLINIC THAT IT WAS USED FOR A SHORT TIME, AND THE DEVICE GAVE AN ERROR MESSAGE INDICATING IT WAS "OVERHEATING." INFANT MONITORED, BILIRUBIN WAS DOWNTRENDING, SO NO ADDITIONAL PHOTOTHERAPY WAS ORDERED. NO PATIENT HARM.