BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMIDAIRE 3I - AMERICAS

    MDR report key: 2161704 · Received July 8, 2011

    Report

    Report Number
    3004604967-2011-00037
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K013843
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED WAS INFORMED THE AIR TUBING WAS NOT CONNECTED TO THE HUMIDIFIER AND THE DEVICE WAS NO IN-USE AT THE TIME OF OCCURRENCE. THERE ARE NO ALLEGATIONS OF A DEVICE MALFUNCTION AND THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PT'S WIFE FELL OUT OF BED ON TOP OF A RESMED HUMIDIFIER AND SUFFERED A LACERATION ON HER CHEEK REQUIRING STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDAIRE 3I - AMERICAS BZD RESMED LTD 33906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other