BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER W/ADULT MASK AND TBG, SMALL VOL

    MDR report key: 4163254 · Received July 16, 2014

    Report

    Report Number
    3004365956-2014-00253
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 30, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES ON THE PRODUCT OR ITS COMPONENTS DURING THE MANUFACTURE OF THE MATERIAL. A CORRECTIVE ACTION CANNOT BE APPLIED SINCE IT IS NOT POSSIBLE TO IDENTIFY THE DEFECT REPORTED AND TO INVESTIGATE ITS ROOT CAUSE, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFO PROVIDED, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. HOWEVER CURRENT PRODUCTION WAS VERIFIED TO IDENTIFY ANY ISSUES WERE FOUND. IF THE DEVICE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE UNIT IS NOT CREATING A MIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416447 HUDSON NEBULIZER W/ADULT MASK AND TBG, SMALL VOL SMALL VOLUME NEBULIZER CCQ TELEFLEX 02M1301446

    Patients

    Seq Age Sex Outcome Treatment
    1