BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIBLANKET PLUS HIGH OUTPUT

    MDR report key: 1844323 · Received September 15, 2010

    Report

    Report Number
    1844323
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 13, 2010
    Manufacturer
    DATEX OHMEDA/GE
    Product Code
    LBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN A BREASTFEEDING POSITION WHEN MOTHER NOTICED ONE SUPERFICIAL LINEAR ABRASION ALONG WITH TWO RED LINEAR MARKS ON THE RIGHT INNER THIGH. THE ABRASION APPEARED TO BE A SCRATCH. UPON REMOVING THE PAPER COVERING ON THE TUBING OF THE OMEDA BILI-BLANKET, IT WAS NOTED BY RN THAT THE PLASTIC COVER OF THE OMEDA PHOTOTHERAPY TUBING WAS SEPARATED FROM THE BILI-BLANKET. A HOLE WAS NOTED ON THE OUTER COVERING AND A FIRM PIECE OF PLASTIC WAS PROTRUDING. THAT BILI-BLANKET UNIT WAS IMMEDIATELY REPLACED WITH AN INTACT UNIT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================ACCORDING TO THE BIOMEDICAL TECHNICIAN, THE INTEGRITY OF THE PROTECTIVE SHEATH ON THE PROXIMAL (PATIENT-END) END OF THE TUBING WAS COMPROMISED EXPOSING A SHARP PROTRUSION (MATERIAL NOT KNOWN/AVAILABLE). THE EXPOSED TIP SCRATCHED THE INFANT AND CAUSED MINOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY, NEONATAL LBI DATEX OHMEDA/GE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY