BEUDAMED
    FDA Adverse Event Other Summary report: N

    2000I

    MDR report key: 554741 · Received November 3, 2004

    Report

    Report Number
    554741
    Event Type
    Other
    Date Received
    November 3, 2004
    Date of Event
    October 30, 2004
    Report Date
    November 3, 2004
    Manufacturer
    VAPOTHERM , INC.
    Product Code
    CAF
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING KEPT ON VAPOTHERM, HIGH FLOW NASAL CANNULA SYSTEM, AND THAT UNIT WAS NOTED TO BE MALFUNCTIONING FOR SEVERAL HOURS UNTIL IT WAS PULLED. WHEN QUESTIONED, THE RT TRIED MULTIPLE WAYS TO DEAL WITH THE PROBLEM WHICH WAS UNSUCCESSFUL AND REPORTED THAT VARIOUS THINGS WERE TRIED BEFORE PULLING THE EQUIPMENT SO IT DID NOT END UP BACK IN CIRCULATION IN THE DEPARTMENT. THE PATIENT EXPERIENCED INCREASED OXYGEN REQUIREMENTS AND BASCIALLY GOT TO THE POINT WHERE THE PATIENT DECOMPENSATED AND WAS NEAR NEEDING TO BE INTUBATED. THE MALFUNCTIONING UNIT WAS PULLED AND WAS REPLACED WITH A UNIT THAT WAS FUNCTIONING PROPERLY. WITHIN LITERALLY MINUTES THE PATIENT COMPLETELY TURNED AROUND, RESPIRATIONS STABLIZED AND STAFF WAS ABLE TO WEAN THE PATIENT FROM 100% OXYGEN TO 70% WHEN THEY HAD NOT BEEN ABLE TO DO THAT ALL DAY. FURTHER INFORMATION REVEALS: ABSENCE OF VISUAL AND AUDIO ALARMS WHEN THE GAS STOPPED FLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2000I NEBULIZER CAF VAPOTHERM , INC. 2001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *