BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON THERMAGARD NEBULIZER HEATER

    MDR report key: 3963190 · Received May 20, 2014

    Report

    Report Number
    1044475-2014-00140
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 6, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION 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. THE UNIT WAS BEING PRE-TESTED PRIOR TO USE ON A PATIENT. THE HEATER HAD TO BE SWITCHED OUT FOR ANOTHER HEATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298585 HUDSON THERMAGARD NEBULIZER HEATER LARGE VOLUME NEBULIZER HEATER BTT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1