BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON THERMAGARD NEBULIZER HEATER

    MDR report key: 3181894 · Received June 17, 2013

    Report

    Report Number
    1044475-2013-00086
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 31, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 EVENT IS REPORTED AS: THE UNIT WILL NOT HOLD ANY PRESSURE DURING PRE-TEST, BY THE END-USER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273390 HUDSON THERMAGARD NEBULIZER HEATER LARGE VOLUME NEBULIZER HEATER BZE TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1