BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON COMFORT FLO HUMIDIFICATION SYSTEM

    MDR report key: 1963306 · Received December 17, 2010

    Report

    Report Number
    3004365956-2010-00369
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 1, 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 WILL NOT BE AVAILABLE FOR EVAL BY MANUFACTURER. THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE PT IS REPORTED AS: THE CIRCUIT DISCONNECTED AT THE CONNECTION OF THE TYGON TUBING TO THE CUFF CONNECTOR NEAR THE COLUMN. 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 02M0901201

    Patients

    Seq Age Sex Outcome Treatment
    1