BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, ACCESSORY

    MDR report key: 8267234 · Received January 22, 2019

    Report

    Report Number
    8267234
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    December 3, 2018
    Report Date
    December 26, 2018
    Manufacturer
    DRAEGER, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE ON PATIENT THE FLOW SENSOR FAILED. THE FLOW SENSOR WAS CHANGED AND EXPIRATORY VALVE RESEATED. THE DEVICE FAILED AGAIN. PER MANUFACTURER'S RESPONSE TO THE HOSPITAL, THE FLOW SENSOR CABLE AND FLOW SENSOR SWITCH WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60083 VENTILATOR, CONTINUOUS, ACCESSORY CBK DRAEGER, INC V500

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA