BILISOFT 2.0
Received Jan 2, 2026 · Event occurred Oct 12, 2025
Report 23943066 · MDR key 23943066
Device
Generic name
Unit, Neonatal Phototherapy
Manufacturer
Lumitex Medical Devices, IncPatient
3 DA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON [REDACTED], DURING PATIENT CARE, THE RN NOTED A BURNING SMELL IN THE ROOM. THE RN PROMPTLY INVESTIGATED AND NOTED THAT THE SMELL EMANATED FROM THE BILISOFT 2.0 PHOTOTHERAPY BLANKET BOX. THE RN TURNED OFF THE PHOTOTHERAPY LIGHT AND INSPECTED THE DEVICE. UPON INSPECTION, SIGNS OF BURNING METAL WERE OBSERVED WITHIN THE DEVICE, SPECIFICALLY AT THE FIBER OPTIC CONNECTION POINT OF THE CORD NEAR THE BOX. THE DEVICE WAS PROMPTLY REMOVED FROM USE AND SEQUESTERED. A REPLACEMENT DEVICE WAS UTILIZED WITHOUT DELAY, AND NO HARM OCCURRED TO THE PATIENT. NO DEVIATION FROM INTENDED PROCEDURE. PHOTOTHERAPY BLANKET HAD BEEN FUNCTIONING CORRECTLY, AND STAFF HAD CONFIRMED IRRADIANCE LEVELS WERE APPROPRIATE FOR THERAPY.