BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT INTENSIVE CARE SYSTEM

    MDR report key: 1660875 · Received April 7, 2010

    Report

    Report Number
    2510954-2010-00004
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Date of Event
    February 23, 2010
    Report Date
    April 6, 2010
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.(PNC)
    Product Code
    FMT
    PMA / PMN Number
    K875270
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE STILL INVESTIGATING THIS REPORTED INCIDENT. WE WILL SUBMIT A F/U REPORT AS SOON AS WE COMPLETE OUR INVESTIGATION.

    Description of Event or Problem · 1

    A PT WAS IN THE RADIANT WARMER. THE RN AT THE PT BEDSIDE WAS PREPARING FOR A PORTABLE X-RAY TEST. THE OVERHEAD RADIANT WARMER COMPARTMENT WAS UNLATCHED TO MOVE TO THE SIDE OF THE BED TO ALLOW THE X-RAY MACHINE TO BE PLACED OVER THE PT'S BODY. THE RN NOTICED A BURNING SMELL IN THE VICINITY AND NOTED SMOKE COMING FROM THE REAR ASPECT OF THE OVERHEAD RADIANT WARMER COMPARTMENT. THE UNIT WAS UNPLUGGED FROM THE WALL. THE PT WAS HELD IN THE NURSES ARMS. THE UNIT WAS REMOVED FROM THE NURSERY. THE BIOMEDICAL DEPT WAS CONTACTED AND CAME IMMEDIATELY TO INVESTIGATE. THE PT WAS TRANSFERRED TO ANOTHER RADIANT WARMER. THERE WAS NO INJURY TO ANY PTS OR STAFF MEMBERS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT INTENSIVE CARE SYSTEM INFANT WARMER FMT DRAEGER MEDICAL SYSTEMS, INC.(PNC) IICS90 7810 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA