BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON LARGE VOLUME NEBULIZER

    MDR report key: 1993861 · Received January 12, 2011

    Report

    Report Number
    3004365956-2011-00024
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Report Date
    December 20, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RETURNED TO MFR AT TIME OF THIS REPORT. INVESTIGATION INCOMPLETE. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE NEBULIZER DOES NOT COMPLETELY ALL THE WATER OUT OF THE BOTTLE. THE NEBULIZER BOTTLE HAS TO BE CHANGED TOO FREQUENTLY. USED DURING TREATMENT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON LARGE VOLUME NEBULIZER LARGE VOLUME NEBULIZER CAF TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK