BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON THERMAGARD NEBULIZER HEATER

    MDR report key: 3833112 · Received March 24, 2014

    Report

    Report Number
    1044475-2014-00077
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 10, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE UNIT WILL NO LONGER HEAT UP. THE ALLEGED ISSUE WAS DETECTED DURING PRE-TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172317 HUDSON THERMAGARD NEBULIZER HEATER LARGE VOLUME NEBULIZER HEATER BTT TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1