BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 2222891 · Received August 10, 2011

    Report

    Report Number
    2518422-2011-00085
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR INOPERATIVE CODE (ERROR 009) WAS FOUND IN A VENTILATOR'S DOWNLOADED ERROR LOG WHILE EVALUATING THE DEVICE. THERE WAS NO ALLEGATION OF A LOSS OF THERAPY BY THE CUSTOMER .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. THE VENTILATOR'S BLOWER MOTOR WAS EVALUATED BY THE MANUFACTURER'S ENGINEERING DEPARTMENT. THE VENTILATOR INOPERATIVE CONDITION WAS FOUND TO HAVE BEEN CAUSED BY A FAULTY BLOWER MOTOR BEARING. THERE WAS NO PATIENT HARM OR INJURY. THE VENTILATOR WAS FOUND TO AUDIBLY AND VISUALLY ALARM APPROPRIATELY FOR A VENTILATOR INOPERATIVE CONDITION. 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. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1