BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUATHERM III, ELECTRONIC HEATER

    MDR report key: 4023752 · Received August 14, 2014

    Report

    Report Number
    3003898360-2014-00519
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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, SERIAL #(B)(4) WAS MANUFACTURED ON (B)(4) 2011. THE DHR INVESTIGATION FID NOT SHOW ISSUES RELATED TO COMPLAINT. A DOCUMENT ASSESSMENT (FMEA) WAS CONDUCTED AND NO CHANGES WERE REQUIRED. CORRECTIVE ACTIONS CAN NOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE DEFECT. AT THIS TIME THE DEVICE SAMPLE IS NOT AVAILABLE, THUS IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. THE COMPLAINT CAN NOT 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. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. 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 TEMPERATURE CONTROL DIAL IS BENT AND THE UNIT WILL NOT PRODUCE HEAT. THE UNIT WAS CHANGED OUT. NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486106 HUDSON AQUATHERM III, ELECTRONIC HEATER LARGE VOLUME NEBULIZER HEATER BTT TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1