BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVE

    MDR report key: 2082712 · Received April 27, 2011

    Report

    Report Number
    2031702-2011-00088
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PLACED ON THE VENTILATOR FOR TRANSPORT. THE PATIENT CIRCUIT "POPPED OFF" THE CONNECTION PORT MULTIPLE TIMES DURING THE TRANSPORT RESULTING IN DIFFICULTY MAINTAINING CIRCUIT PRESSURE. THE PATIENT'S SPO2 LEVEL DECLINED. THE PATIENT'S STATUS IS UNAVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention