BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3955778 · Received July 24, 2014

    Report

    Report Number
    2031702-2014-00177
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    September 4, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: WIRE CONNECTION FROM THE SOLENOID MOUNT ASSEMBLY HAD DISCONNECTED FROM THE POWER BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS NOT HOLDING PEEP WHERE IT KEEPS DROPPING TO ZERO AT 5CMH2O SETTING. THE REPORTED PROBLEM OCCURRED DURING PRE-TEST AND THE VENTILATOR WAS NOT CONNECTED TO A PATIENT. THERE WAS AN AUDIBLE ALARM WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434244 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1