BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3003402 · Received February 13, 2013

    Report

    Report Number
    2031702-2013-00024
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Report Date
    February 13, 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
    AZ, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS AUTOCYCLING AND STACKING BREATHS EVERY 3RD TO 4TH BREATH WHILE CONNECTED TO A PT. NO PT HARM REPORTED. IT IS UNK IF THE VENTILATOR ALARMED WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63970 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203 INC LTV 1150 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI