BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE

    MDR report key: 5060203 · Received September 8, 2015

    Report

    Report Number
    5060203
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 11, 2015
    Manufacturer
    CAREFUSION 2200, INC.
    Product Code
    CAG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STAFF WENT TO REPOSITION THE VENTILATOR CIRCUIT AND IT RIPPED A HOLE IN THE EXPIRATORY LIMB. THE HOLE WAS CAUSED BY THE CIRCUIT MELTING THE TEMP PROBE WIRE AND IT CAME APART WHEN MOVED. WE HAVE SEEN THIS TYPE OF EVENT BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592314 AIRLIFE VENTILATOR BREATHING CIRCUIT CAG CAREFUSION 2200, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1