BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE INFANT WARMER

    MDR report key: 3202296 · Received June 25, 2013

    Report

    Report Number
    MW5030709
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 25, 2013
    Manufacturer
    GE HEALTHCARE
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WHO WAS A NEWBORN INFANT WAS PLACED IN A GE PANDA INFANT WARMER AT BIRTH. EQUIPMENT WAS SET ON THE PROBE. STAFF AND INFANT'S FATHER NOTICED A LOT OF SMOKE COMING OUT OF THE BACK OF THE WARMER AND A SMOKE ALARM IN THE ROOM WAS TRIGGERED. BABY WAS REMOVED FROM THE EQUIPMENT, AND MOTHER AND BABY MOVED TO A DIFFERENT ROOM. BABY WAS PLACED IN ANOTHER WARMER. THE MALFUNCTIONING EQUIPMENT, AND MOTHER AND BABY MOVED TO A DIFFERENT ROOM. BABY WAS PLACED IN ANOTHER WARMER. THE MALFUNCTIONING EQUIPMENT WAS REMOVED FROM SERVICE AND SEQUESTERED. THIS WAS A FAIRLY NEW PIECE OF EQUIPMENT -1 OF 8 PURCHASED AT THE SAME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288026 GE HEALTHCARE INFANT WARMER PANDA INFANT WARMER FMT GE HEALTHCARE M1112198-025620

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Required Intervention