BEUDAMED
    FDA Adverse Event Other Summary report: N

    H41 - AMERICAS

    MDR report key: 2270768 · Received September 23, 2011

    Report

    Report Number
    3004604967-2011-00050
    Event Type
    Other
    Date Received
    September 23, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 23, 2011
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K080131
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT WAS ADMITTED TO ICU FOR PNEUMONIA AFTER ALLEGING A BURNING SMELL WAS OBSERVED FROM THEIR H4I DEVICE. THE PATIENT HAS HAD PREVIOUS EPISODES OF PNEUMONIA, BUT IT WAS ALLEGED THAT THE BURNING SMELL EXACERBATED THE PNEUMONIA. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS LATER AND IS CURRENTLY DOING WELL. THE DEVICE IN QUESTION HAS NOT BEEN RETURNED TO RESMED, HOWEVER THE DME DID THEIR OWN TESTING AND WAS UNABLE TO DUPLICATE A BURNING SMELL OR ANY OTHER ABNORMAL ODORS. RESMED HAS MADE REQUESTS FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. AS THIS HAS NOT OCCURRED, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION OR THE POSSIBILITY THE DEVICE CONTRIBUTED TO THE PATIENT'S CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED A PATIENT USING A H4I HUMIDIFIER WAS ADMITTED TO ICU FOR PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H41 - AMERICAS BZD RESMED LTD 26940

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening