BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON THERMAGARD NEBULIZER HEATER

    MDR report key: 3131247 · Received May 23, 2013

    Report

    Report Number
    1044475-2013-00081
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 9, 2013
    Manufacturer
    TELEFLEX
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 EVENT IS REPORTED AS: THE CUSTOMER REPORTS THAT UNIT IS NOT WORKING. THE POWER LIGHTS FLICKERS AND/OR UNIT NOT HEATING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230087 HUDSON THERMAGARD NEBULIZER HEATER LARGER VOLUME NEBULIZER HEATER BZE TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1