BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON COMFORT FLO HUMIDIFICATION SYSTEM

    MDR report key: 6158794 · Received December 9, 2016

    Report

    Report Number
    3004365956-2016-00443
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 13, 2016
    Report Date
    November 16, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE DEVICE INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE DEVICE WAS NOT RETURNED AT THE TIME OF THIS REPORT. THERE WAS NO PHOTO PROVIDED OF THE ALLEGED DEFECT. A DEVICE HISTORY RECORD INVESTIGATION SHOWS THAT THE DEVICE WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. TO PERFORM A PROPER INVESTIGATION, AND DETERMINE THE SOURCE OF THE ALLEGED DEFECT REPORTED, IT IS NECESSARY TO EVALUATE THE DEVICE INVOLVED IN THIS COMPLAINT. ROOT CAUSE IS UNKNOWN AT THIS TIME. IF THE DEVICE SAMPLE BECOMES AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "WATER BACKED UP IN COLUMN SENDING WATER BACK TO THE PATIENT THROUGH THE CANNULA". THE ALLEGED DEFECT WAS DETECTED DURING USE. THERE WAS NO PATIENT INJURY OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808022 HUDSON COMFORT FLO HUMIDIFICATION SYSTEM HUMIDIFIER NEBULIZER KIT OGG TELEFLEX MEDICAL 74H1600052

    Patients

    Seq Age Sex Outcome Treatment
    1