BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2071118 · Received April 27, 2011

    Report

    Report Number
    2031642-2011-00119
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 29, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED O2 VALVE STUCK CLOSED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED EVENT. REVIEW OF THE VENTILATOR'S DIAGNOSTIC LOG HISTORY NOTED THE REPORTED OCCURRENCE. UPON DETECTION OF AN OXYGEN VALVE STUCK CLOSED, THE VENTILATOR WILL ALARM AND CONTINUE TO VENTILATE USING AN AIR GAS SOURCE. LOSS OF THE OXYGEN SOURCE CAN BE DETRIMENTAL TO A PATIENT IF THIS TYPE OF EVENT OCCURS. EXTENDED SELF TESTING AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS.

    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