BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3884943 · Received June 19, 2014

    Report

    Report Number
    2031702-2014-00157
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR STOPPED VENTILATING BRIEFLY. IT IS UNKNOWN IF THE VENTILATOR HAD AN AUDIBLE ALARM WHEN THE REPORTED PROBLEM OCCURRED. THE VENTILATOR WAS SHUT DOWN AND POWERED BACK ON AND CONTINUED TO VENTILATE CORRECTLY. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359602 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1