BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUAPAK HUMIDIFIER, STERILE WATER, 340ML

    MDR report key: 2090147 · Received April 11, 2011

    Report

    Report Number
    1417411-2011-00043
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Report Date
    March 21, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MANUFACTURER, HOWEVER, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING NEBULIZER TREATMENTS, THE BOTTLE MAKES A WHISTLING NOISE WHEN THE FLOW IS SET AT 2LPM. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON AQUAPAK HUMIDIFIER, STERILE WATER, 340ML AQUAPAK HUMIDIFIER BTT TELEFLEX MEDICAL NA 376107

    Patients

    Seq Age Sex Outcome Treatment
    1