BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER W/PED MASK & TUBING

    MDR report key: 3231996 · Received July 15, 2013

    Report

    Report Number
    3004365956-2013-00235
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    March 27, 2013
    Report Date
    June 26, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW RECORDS OF ISSUES WITH THE MATERIAL AT THE TIME IT WAS ASSEMBLED. THE COMPLAINT CANNOT BE CONFIRMED WITH THE INFO PROVIDED. IN ORDER TO PERFORM A PROPER INVESTIGATION TO DETERMINE A CORRECTIVE ACTION, IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THE INCIDENT.

    Description of Event or Problem · 1

    THE COMPLAINT REPORTED AS: THE CUSTOMER ALLEGES THAT THE MASK DID NOT AERATE LIQUID IN THE CHAMBER TO FORM ADEQUATE MIST. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326705 HUDSON NEBULIZER W/PED MASK & TUBING SMALL VOLUME NEBULIZER CAF TELEFLEX MEDICAL 02H1201956

    Patients

    Seq Age Sex Outcome Treatment
    1