BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCHA NEPTUNE HEATER

    MDR report key: 2020585 · Received February 10, 2011

    Report

    Report Number
    3003898360-2011-00039
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION, THEREFORE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE UNIT BEGAN TO SMOKE. COMPLAINT ALLEGES THE YELLOW WIRE IS SET ON THE MACHINE INCORRECTLY ALLOWING WATER INTO THE PROBE CONNECTION. IT WAS ON A PATIENT AT THE TIME, BUT NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCHA NEPTUNE HEATER HEATER BTT TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1