BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1960058 · Received January 13, 2011

    Report

    Report Number
    2031642-2011-00002
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 15, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIRECTOR OF RESPIRATORY CARE REPORTED THE FOLLOWING: THE PATIENT'S OXYGEN SATURATION DROPPED INTO THE 70'S DURING WEANING FROM THE VENTILATOR. DURING THE EVENT, THE VENTILATOR DISPLAYED +++ ON THE MONITOR SCREEN AND WAS ALARMING, AND WAS ALSO ALARMING AT THE CENTRAL ALARM STATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND BAGGED. THE MANUFACTURER'S SERVICE TECHNICIAN PERFORMED EVALUATION AND TESTING OF THE VENTILATOR ON PATIENT SETTINGS AT TIME OF THE EVENT, AND REPORTED IT PERFORMED TO SPECIFICATIONS. THE SERVICE TECHNICIAN REPORTED THAT REVIEW OF THE TRENDING INFORMATION IN THE VENTILATOR CONFIRMED +++ NOTED IN THE TOTAL RATE PARAMETER, INDICATING THE TOTAL RESPIRATORY RATE HAD INCREASED OUT OF RANGE. THE PATIENT WAS NOT TOLERATING THE WEANING WELL, AND WAS COUGHING UP MUCUS PLUGS. THERE WAS NO PERMANENT HARM, AND THE PATIENT IS STILL BEING WEANED AND IS DOING WELL. THEY DO NOT BELIEVE THE VENTILATOR CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention