BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTECH CANNULA

    MDR report key: 28128 · Received November 8, 1995

    Report

    Report Number
    2014730-1995-00007
    Event Type
    Injury
    Date Received
    November 8, 1995
    Date of Event
    October 24, 1995
    Report Date
    November 8, 1995
    Manufacturer
    HOSPITAK, INC.
    Product Code
    CAI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT IN CARDIAC COMPROMISE WAS PLACED ON AN OXYGEN CANNULA. THE PT WAS OBSERVED TO BE DESATURATED. THE CANNULA WAS CHECKED AND FOUND TO BE OCCLUDED. THE CANNULA WAS CHANGED AND THE PT'S SATURATION RETURNED TO NORMAL. THE CANNULA WAS RETURNED TO THE DISTRIBUTOR AND THE OCCLUSION WAS CONFIRMED. THE CANNULA WAS THEN FORWARDED TO THE MFR FOR THE INVESTIGATION. THE LABEL PROVIDED WITH THE CANNULA STATES TO CHECK DEVICE FOR AIRFLOW PRIOR TO USE. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTECH CANNULA NASAL OXYGEN CANNULA CAI HOSPITAK, INC. NA 95034

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention