BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTOTHERAPY BILIBLANKET

    MDR report key: 25259324 · Received May 22, 2026

    Report

    Report Number
    25259324
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    March 8, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BISTOS CO., LTD.
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160597 PHOTOTHERAPY BILIBLANKET UNIT, NEONATAL PHOTOTHERAPY LBI BISTOS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Female Other