BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 1882567 · Received October 22, 2010

    Report

    Report Number
    2031702-2010-00209
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 21, 2010
    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, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE RN THAT THE VENTILATOR MAY HAVE BEEN SET IMPROPERLY BY THE RT FOR TRANSPORT WHICH CAUSED THE PATIENT TO "CODE" WHILE ON THE VENTILATOR. THE RT STATED THE PIP WAS READING LOW AND THAT THE RT HAD TO SET THE PRESSURE CONTROL TO 40 TO GET A PIP OF 30. THE RT COMMENTED ON LOW CHEST RISE. WHEN THE FLIGHT NURSE CHECKED THE VTE AND FOUND IT TO BE READING 80, THE RT STATED THAT THE VENTILATOR NEEDED TO BE CALIBRATED. THE RN STATED THAT THE CHILDS VTE SHOULD HAVE BEEN AROUND 30. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND NEEDED TO BE MANUALLY VENTILATED FOR THE DURATION OF THE TRANSPORT. THE TRANSPORT WAS COMPLETED WITHOUT FURTHER INCIDENT.

    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 35 DA Life Threatening| R