BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA

    MDR report key: 1897196 · Received October 21, 2010

    Report

    Report Number
    1897196
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 21, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    VENTILATOR CAME INTO THE SHOP FOR ROUTINE SERVICE. DUE TO PAST PROBLEMS WITH THE NEBULIZER PUMPS, THE UNIT WAS CHECKED FOR BLACK DUST BY CONNECTING A CATCH TUBE TO THE NEBULIZER OUT PORT. THE TUBE COLLECTED BLACK DUST FROM THE NEBULIZER PORT. WHEN CONNECTED TO A PATIENT CIRCUIT, THIS BLACK DUST WOULD BE ADMINISTERED TO THE PATIENT. PHOTOS OF THE INSIDE OF THE NEBULIZER PUMP WERE TAKEN CONFIRMING THE PRESENCE OF BLACK DUST.======================HEALTH PROFESSIONAL'S IMPRESSION======================DETERIORATION OF THE SEAL IN THE NEBULIZER PUMP CREATES BLACK DUST THAT IS THEN ADMINISTERED TO THE PATIENT. PHOTOS OF THE INSIDE OF THE NEBULIZER PUMP WERE TAKEN CONFIRMING THE DETERIORATION AND PRESENCE OF THE BLACK DUST.====================== MANUFACTURER RESPONSE FOR VENTILATOR, AVEA======================THEY HAVE NOT RESPONDED TO THIS EVENT YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVEA VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 17210-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *