BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 5021699 · Received August 21, 2015

    Report

    Report Number
    2031702-2015-00180
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Report Date
    August 21, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN FOUND THE FLOW VALVE SPRING WAS BROKEN. THE FLOW VALVE WAS REPLACED TO CORRECT THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR HAD LOW VOLUME DELIVERY. ACCORDING TO THE FIELD SERVICE TECHNICIAN, THE 400ML DELIVERY WAS 225 AND O2 WAS DELIVERING REALLY HIGH AT 80% WHEN SET AT 60%. NO PATIENT ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555144 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1000

    Patients

    Seq Age Sex Outcome Treatment
    1