BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 4200730 · Received October 24, 2014

    Report

    Report Number
    2031702-2014-00235
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 24, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE VENTILATOR ALARMED, IT DID NOT SEND AN ALARM TO THE NURSE CALL SYSTEM. THE NURSE WAS ABLE TO HEAR THE VENTILATOR ALARMING. NO PATIENT HARM REPORTED. THE NURSE CHANGED THE PATIENT ASSIST CABLE BUT IT DID NOT SEND AN ALARM TO THE NURSE CALL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680299 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 900

    Patients

    Seq Age Sex Outcome Treatment
    1