BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE INCUBATOR

    MDR report key: 1873129 · Received September 28, 2010

    Report

    Report Number
    1873129
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 28, 2010
    Manufacturer
    GENERAL ELECTRIC HEALTHCARE
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A LOUD NOISE AND SPARKS WERE SEEN COMING FROM THE ELECTRICAL OUTLET BEHIND AN ISOLETTE IN THE NICU. UPON INSPECTION, THERE WAS A FRAYED AREA THAT HAD MADE A HOLE THROUGH THE CORD CONNECTED TO THE ISOLETTE PLUG.BIOMED CONTACTED THE MANUFACTURER OF THE ISOLETTE. THE MANUFACTURER HAD CHANGED THE WAY THEY WRAP THE CORD. THERE WILL BE A DESIGN CHANGE MADE FOR FUTURE MODELS.VELCRO STRAPS WERE ADDED TO THE CORDS OF CURRENT ISOLETTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE INCUBATOR INCUBATOR, INFANT FMZ GENERAL ELECTRIC HEALTHCARE UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 *