BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3427609 · Received October 24, 2013

    Report

    Report Number
    2031702-2013-00235
    Event Type
    Malfunction
    Date Received
    October 24, 2013
    Date of Event
    September 24, 2013
    Report Date
    October 24, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PLACED ON THE VENTILATOR BY THE RT IN THE HOSPITAL WHEN IT SHUT DOWN WITH A HDW FAULT ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON ANOTHER VENTILATOR. NO PATIENT HARM AS CLINICIAN WAS PRESENT. BIOMED AT THE FACILITY WAS ABLE TO DUPLICATE THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547523 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1