BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPOTHERM

    MDR report key: 979550 · Received December 19, 2007

    Report

    Report Number
    979550
    Event Type
    Malfunction
    Date Received
    December 19, 2007
    Date of Event
    November 29, 2007
    Report Date
    December 19, 2007
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT FOUND TO BE DESATURATING IN THE 60'S AFTER REQUIRING INCREASED FIO2. VAPOTHERM INFANT NASAL CANNULA FOUND TO HAVE COME APART BETWEEN THE PRONGS AND THE SIDE OF THE CANNULA. CANNULA REMOVED AND NEW ONE CONNECTED. SATURATIONS IMPROVED TO WITHIN NORMAL LIMITS. MANUFACTURER RESPONSE FOR NASAL CANNULA, VAPOTHERM: NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM CANNULA, NASAL CAT VAPOTHERM, INC. * 122405

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO