BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUATHERM III, ELECTRONIC HEATER

    MDR report key: 3963205 · Received May 20, 2014

    Report

    Report Number
    3003898360-2014-00335
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. PER DHR (DEVICE HISTORY RECORD), THE PRODUCT AQUATHERM III, ELECTRONIC HEATER, LOT #6061100004 MANUFACTURED ON 12/12/2013. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. THE COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE UNIT WOULD NO LONGER HEAT. THE DEVICE WAS NOT IN USE ON A PATIENT WHEN THE UNIT EXPERIENCED THE ALLEGED POWER FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298394 HUDSON AQUATHERM III, ELECTRONIC HEATER LARGE VOLUME NEBULIZER HEATER BTT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1