BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 2161229 · Received July 8, 2011

    Report

    Report Number
    2031702-2011-00146
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    May 25, 2011
    Report Date
    July 7, 2011
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS PREVIOUSLY SERVICED AT A FIELD SERVICE CENTER. THE FIELD SERVICE CENTER WILL BE NOTIFIED OF THE FAILURE INVESTIGATION RESULTS. RESULT: MIS-ROUTING OF TUBING AND PINCHED WIRE CAUSED BY PRIOR MAINTENANCE AT THE FIELD SERVICE CENTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, THE VTE WAS JUST OVER 100ML, EVEN THOUGH VT WAS SET AT 600ML. THERE WAS NO CHEST RISE AND SPO2 LEVELS DROPPED QUICKLY. THERE WAS AN AUDIBLE ALARM WHEN THE REPORTED PROBLEM OCCURRED. THE PATIENT WAS MANUALLY VENTILATED. WHILE THE VENTILATOR WAS CONNECTED TO A TEST LUNG, THE VTE WAS ONLY 300-350 WITH SET VT OF 600. NO PATIENT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention