BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HME -HEALTH MOISTURE EXCHANGER-

    MDR report key: 1664416 · Received April 15, 2010

    Report

    Report Number
    MW5015592
    Event Type
    Injury
    Date Received
    April 15, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 15, 2010
    Manufacturer
    UNKNOWN
    Product Code
    BYD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS NEAR CODE BLUE - CAUSE WAS DUE TO THE VENTILATOR HME IN-LINE FILTER COLLECTION OF EXCESSIVE AMOUNT OF WATER/MOISTURE NOT ALLOWING PROPER VENTILATION TO PT. FILTER CHANGED OUT, PT MOVED TO ICU FOR MONITORING - NO HARM NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HME -HEALTH MOISTURE EXCHANGER- IN-LINE FILTER BYD UNKNOWN BB100AF

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR