BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SMALL VOLUME NEBULIZER

    MDR report key: 2201562 · Received August 3, 2011

    Report

    Report Number
    3004365956-2011-00311
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE NEBULIZER WOULD NOT MIST ONCE IT WAS CONNECTED TO THE COMPRESSOR. THE REPORTED DEFECT WAS DISCOVERED PRIOR TO PATIENT USE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SMALL VOLUME NEBULIZER SMALL VOLUME NEBULIZER CAF TELEFLEX MEDICAL NA 02D0900428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA