BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 1983818 · Received January 21, 2011

    Report

    Report Number
    2031702-2011-00265
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS GOING INTO A RESET CONDITION AND THIS OCCURRED WHILE ON A PT. THERE WAS NO PT HARM REPORTED, THE UNIT DID ALARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI