BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 5069396 · Received September 10, 2015

    Report

    Report Number
    2031702-2015-00205
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Report Date
    September 10, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN HAD TESTED THE VENTILATOR AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD READINGS THAT WERE LOW. WHEN THE VENTILATOR BREATH RATE WAS SET TO 25, IT WAS READING A BREATH RATE OF 18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600422 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1000

    Patients

    Seq Age Sex Outcome Treatment
    1