BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3196796 · Received June 21, 2013

    Report

    Report Number
    2031702-2013-00142
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE NURSE TURNED THE VENTILATOR OFF AND BACK ON AGAIN TO START NORMAL OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOMECARE NURSE HAD INITIATED A SPONTANEOUS BREATHING TRIAL (SBT) EVEN THOUGH THE CONTROL LOCK WAS ENGAGED ON THE VENTILATOR. THE PT WAS MANUALLY VENTILATED. THE NURSE HAD TO TURN THE VENTILATOR OFF AND THEN RE-START THE VENTILATOR. NORMAL OPERATION RESUMED AND THE PT WAS PLACED BACK ON THE VENTILATOR. THE VENTILATOR WAS ALARMING DURING THE INCIDENT. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282661 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC. LTV 1150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI