BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 2243998 · Received August 24, 2011

    Report

    Report Number
    2518422-2011-00096
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR ALARMED AND STOPPED DELIVERING AIRFLOW. THERE WAS NO PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A VENTILATOR INOPERATIVE CODE (ERROR 009) WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE LOGGED ERROR CODE 009 INDICATES A POTENTIAL MALFUNCTION OF THE VENTILATOR'S BLOWER MOTOR. THE DEVICE'S BLOWER MOTOR WAS REPLACED TO ADDRESS THE LOGGED ERROR CODE AND CUSTOMER COMPLAINT. THERE WAS NO PATIENT HARM OR INJURY. THE VENTILATOR WAS FOUND TO AUDIBLY AND VISUALLY ALARM AS DESIGNED TO ALERT A CAREGIVER OF AN EVENT. THE MANUFACTURER WILL CONTINUE TO TREND LIFE SUPPORT VENTILATOR MALFUNCTIONS THAT COULD POTENTIALLY RESULT IN A LOSS OF THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS, FACILITY USE TRILOGY 100 CBK RESPIRONICS INC. 1054655

    Patients

    Seq Age Sex Outcome Treatment
    1