BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON MICRO MIST SMALL VOLUME NEBULIZER

    MDR report key: 3994424 · Received July 23, 2014

    Report

    Report Number
    3004365956-2014-00297
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 26, 2014
    Report Date
    July 4, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD OF BATCH NUMBER 02C1400129 WAS REVIEWED AND THERE WERE NO ISSUES OR DISCREPANCIES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. NO NON-CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "THE MASK DID NOT MIST AFTER FILLING THE CHAMBER AND ADMINISTERING OXYGEN". THE PT CONDITION WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432331 HUDSON MICRO MIST SMALL VOLUME NEBULIZER ADULST SMALL VOLUME NEBULIZER CCQ TELEFLEX 02C1400129

    Patients

    Seq Age Sex Outcome Treatment
    1