BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON AQUATHERM III ELECTRONIC HEATER

    MDR report key: 3032751 · Received March 29, 2013

    Report

    Report Number
    3003898360-2013-00123
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE REPORTED SERIAL NUMBER. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. FMEA (PRODUCT/PROCESS) DOCUMENT REVIEW/ASSESSMENT WAS CONDUCTED AND NO CHANGES WERE REQUIRED. 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 TAKEN FOR IT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THERE WAS NO HEAT COMING FROM THE DEVICE DURING USE ON A PATIENT, EVEN THOUGH THE POWER LAMP WAS ON. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129862 HUDSON AQUATHERM III ELECTRONIC HEATER NEBULIZER HEATER BZE TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1