BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 3796840 · Received May 7, 2014

    Report

    Report Number
    2031702-2014-00117
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS NOT CREATING OUTPUT PRESSURE WHILE CONNECTED TO A PATIENT. THE VENTILATOR DID NOT HAVE AN AUDIBLE ALARM. THE PATIENT HAD MULTIPLE DESATURATION EPISODES. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276527 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1