BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3132359 · Received May 1, 2013

    Report

    Report Number
    2031702-2013-00098
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR RESET AND WOULD NOT POWER BACK UP. IT IS UNK IF THE VENTILATOR ALARMED OR IF IT WAS CONNECTED TO A PT WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190919 LTV VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC LTV 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI