BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3182825 · Received June 11, 2013

    Report

    Report Number
    2031702-2013-00130
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    June 11, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TURBINE WOULD NOT ENGAGE. IT IS UNK IF THE VENTILATOR AUDIBLY ALARMED OR IF IT WAS CONNECTED TO A PT OR WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264537 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC. LTV 950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI NI/NI