BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEWBORN BILI-BONNET

    MDR report key: 810312 · Received January 29, 2007

    Report

    Report Number
    810312
    Event Type
    Death
    Date Received
    January 29, 2007
    Date of Event
    December 31, 2006
    Report Date
    January 29, 2007
    Manufacturer
    SMALL BEGINNINGS INC.
    Product Code
    FOK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    IN NEWBORN NURSERY A FULL-TERM FEMALE BORN VIA VAGINAL DELIVERY WITH APGARS NINE AND NINE NOTED TO BE JAUNDICED WAS STARTED ON PHOTOTHERAPY. SMALL BEGINNINGS NEWBORN BILI-BONNET PHOTOTHERAPY MASK WAS PLACED OVER THE BABY'S EYES. AT TEN HOURS OF AGE THE BABY WAS FOUND NOT BREATHING AND THE MASK WAS FOUND POSITIONED BELOW THE EYES. CODE WAS CALLED AND BABY WAS RESUSCITATED AND TRANSFERRED TO NEONATAL INTENSIVE CARE UNIT. BABY CONTINUED ON LIFE SUPPORT. EVIDENCE OF WORSENING HYPOXIC-ISCHEMIC ENCEPHALOPATHY. AFTER EXTENSIVE DISCUSSION WITH FAMILY, LIFE SUPPORT REMOVED. AUTOPSY PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWBORN BILI-BONNET PHOTOTHERAPY, MASK FOK SMALL BEGINNINGS INC. 01B 07312006FB

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Death OTHER