BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUATHERM III ELECTRONIC HEATER

    MDR report key: 2900783 · Received December 12, 2012

    Report

    Report Number
    3003898360-2012-00602
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    TELEFLEX
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE WITH THE REPORTED COMPLAINT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE ESTABLISHED. MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "HEATER IS WORKING IMPROPERLY. IT DOES NOT HEAT THE AEROSOL." THE DEFECT WAS DISCOVERED DURING USE ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON AQUATHERM III ELECTRONIC HEATER HEATER BTT TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1