BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2492390 · Received March 2, 2012

    Report

    Report Number
    2492390
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 2, 2012
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DISCOVERED A BROKEN FILTER ON THE OSCILLATOR CIRCUIT.NOTICED THAT WE COULD NOT KEEP THE MEAN AIRWAY PRESSURES IN THE ADEQUATE RANGE. UPON INSPECTION OF THE CIRCUIT FOUND THE FILTER CONNECTION TO THE HFOV WAS CRACKED AND LEAKING. THE THERAPIST AND I CHANGED OUT THE BROKEN COMPONENT AND CALIBRATED THE MACHINE. THE MACHINE WAS WORKING FINE WHEN WE LEFT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * VENTILATOR, FILTER LSZ CAREFUSION 2200, INC. 12152 *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR