BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONETIC

    MDR report key: 1612638 · Received February 12, 2010

    Report

    Report Number
    2031702-2010-00023
    Event Type
    Injury
    Date Received
    February 12, 2010
    Report Date
    February 12, 2010
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING HELICOPTER TRANSPORT, THE PATIENT'S ETCO2 READINGS CONTINUED TO FALL WHILE CONNECTED TO THE VENTILATOR. THE VENTILATOR APPEARED TO BE AUTO CYCLING. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED. THE VENTILATOR WAS CHECKED BY THE REPORTING PARTY WITH NO PROBLEMS FOUND. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONETIC VOLUME VENTILATOR CBK CAREFUSION 203, INC. LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention