BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSHIELDS

    MDR report key: 1053195 · Received May 16, 2008

    Report

    Report Number
    1053195
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    April 4, 2008
    Report Date
    May 16, 2008
    Manufacturer
    DRAEGER MEDICAL INC.
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    INFANT BEING ASSESSED WHEN NURSE SMELLED ELECTRICAL SMOKE. SMOKE SEEN ABOVE ISOLETTE. INFANT REMOVED FROM ISOLETTE IMMEDIATELY AND PLACED IN A CLEAN ISOLETTE. CHANGE NURSE NOTIFIED. SECURITY CALLED. HOSPITAL BIOMEDICAL CALLED AND NOTIFIED. BIOMEDICAL SHEET FILLED OUT AND ISOLETTE TAKEN TO DIRTY UTILITY ROOM TO BE CLEANED. NO PROBLEMS WITH INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRSHIELDS INCUBATOR, INFANT FMZ DRAEGER MEDICAL INC. C2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 WK