BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 2240965 · Received August 17, 2011

    Report

    Report Number
    2518422-2011-00088
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFO ALLEGING A VENTILATOR ALARMED AND DISPLAYED A VENTILATOR INOPERATIVE MESSAGE. THERE WAS NO PT HARM OR INJURY. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVAL AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE'S DOWNLOADED ERROR LOG INDICATED AN ERROR 009 HAD OCCURRED. ERROR 009 IS ASSOCIATED WITH POTENTIAL MALFUNCTIONS OF THE VENTILATOR'S BLOWER MOTOR. THE REPAIR TECHNICIAN CONFIRMED THE VENTILATOR INOPERATIVE CONDITION AND RELATED ERROR 009 WERE CAUSED BY AN ELECTRICAL SHORT OF THE BLOWER MOTOR'S COIL. THE BLOWER MOTOR WAS REPLACED TO ADDRESS THE LOGGED ERROR CODE. THERE WAS NO PT 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