BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW CONCENTRATION NASAL OXYGEN CANNULAS

    MDR report key: 2833063 · Received November 5, 2012

    Report

    Report Number
    9680866-2012-00002
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 10, 2012
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    CAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS DEEMED SERIOUS BECAUSE THE RUPTURE IN THE NASAL CANNULA POSSIBLY CAUSED THE PT TO DESATURATE (77%), TO HAVE A LOW HEART RATE (44/MIN) AND TO BECOME CYANOTIC. IF NOT DISCOVERED IN GOOD TIME, THIS AE MAY HAVE LED TO SERIOUS CONSEQUENCES FOR THE PT. IN THIS CASE THE SITUATION WAS CORRECTED BY REPLACING THE AFFECTED CANNULA WITH A NEW ONE. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE NASAL CANNULA AND THIS EVENT IS DEEMED POSSIBLE BECAUSE PRODUCT USE WAS TEMPORALLY ASSOCIATED WITH OCCURRENCE OF THE ADVERSE EVENT.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: THE HUSBAND OF THE PT WAS AWAKENED BY THE GROANS OF HIS WIFE IN A STATE OF MAJOR DYSPNEA AND HYPERVENTILATION. HE MEASURED OXYGEN SATURATION AND HEART RATE USING THE PULSE OXIMETER AND FOUND VERY LOW VALUES (77% AND 44 FC SAO2). BY REVIEWING THE MATERIAL HE FOUND A RUPTURE OF THE NASAL CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW CONCENTRATION NASAL OXYGEN CANNULAS NASAL OXYGEN CANNULAS CAT UNOMEDICAL S.A. DE C.V. NA 11-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R