BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON COMFORT FLO HUMIDIFICATION SYSTEM

    MDR report key: 1915481 · Received November 5, 2010

    Report

    Report Number
    3004365956-2010-00329
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    April 21, 2010
    Report Date
    October 19, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WILL NOT BE AVAILABLE FOR EVALUATION BY MANUFACTURER. INVESTIGATION REPORT BY MANUFACTURER IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT IS SEPARATING FROM THE COLUMN AND EXPOSING WIRES. THE CIRCUIT WAS REMOVED FROM THE PT AND REPLACED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON COMFORT FLO HUMIDIFICATION SYSTEM COMFORT FLO HUMIDIFICATION SYSTEM BTT TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1