BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MICRO MIST NEBULIZER

    MDR report key: 2901491 · Received January 3, 2013

    Report

    Report Number
    3004365956-2013-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. THE REVIEW SHOWED THAT THERE WERE NO ISSUES RELATED TO THE FUNCTIONAL ISSUES, NEITHER ON THE PRODUCT, NOT ITS COMPONENTS DURING THE MANUFACTURE OF THE MATERIAL. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE SAMPLE THAT WAS INVOLVED IN THE INCIDENT WAS NOT PROVIDED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE NEBULIZER WILL NOT STAY CONNECTED TO AN AEROSOL MASK DURING PT USE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2638 HUDSON MICRO MIST NEBULIZER SMALL VOLUME NEBULIZER CAF TELEFLEX MEDICAL 02H1202563

    Patients

    Seq Age Sex Outcome Treatment
    1