BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON COMFORT FLO HUMIDIFICATION SYSTEM

    MDR report key: 1963344 · Received December 17, 2010

    Report

    Report Number
    3004365956-2010-00367
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT DISCONNECTED AT THE CONNECTION OF THE TYGON TUBING TO THE TEMPERATURE PROBE CONNECTOR NEAR THE PT END. THIS RESULTED IN GAS TO THE PT LEAKING BEFORE THE CANNULA CONNECTION. THIS LACK OF OXYGEN TO THE PT SET OFF THE OXIMETER ALARM ALLOWING THE RT TO RESPOND QUICKLY. 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 02F1000307

    Patients

    Seq Age Sex Outcome Treatment
    1