BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT COMFORT FLO NASAL CANNULA

    MDR report key: 6670788 · Received June 27, 2017

    Report

    Report Number
    3011137372-2017-00221
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    June 9, 2017
    Report Date
    June 12, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). BASED ON THE INFORMATION GIVEN BY THE CUSTOMER, THERE ARE 2 MDRS ASSOCIATED WITH THIS COMPLAINT. (SEE MDR 3004365956-2017-00266 FOR COMFORT FLO HUMIDIFICATION SYSTEM). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE HIGH FLOW PRODUCT #2410 (EVENT DOCUMENTED IN MDR 3004365956-2017-00266) WAS USED WITH THE COMFORT FLOW CANNULA 2411-01. THE CANNULA BUILT UP A BACK PRESSURE AND STOPPED FLOW TO THE PATIENT. ALLEGED MALFUNCTION WAS REPORTED AS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT. PATIENT'S CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 1

    THE HIGH FLOW PRODUCT #2410 (EVENT DOCUMENTED IN MDR 3004365956-2017-00266) WAS USED WITH THE COMFORT FLOW CANNULA 2411-01. THE CANNULA BUILT UP A BACK PRESSURE AND STOPPED FLOW TO THE PATIENT. ALLEGED MALFUNCTION WAS REPORTED AS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT. PATIENT'S CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451026 ADULT COMFORT FLO NASAL CANNULA CANNULA, NASAL, OXYGEN CAT TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 COMFORT FLO HUMIDIFICATION SYSTEM