BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1253279 · Received December 9, 2008

    Report

    Report Number
    2031642-2008-00237
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE THE VENTILATOR WAS IN USE ON PATIENT THE MONITOR WENT GRAY AND THE VENTILATOR ALARMED AND STOPPED VENTILATING. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED EVENT. THE SERVICE TECHNICIAN NOTED DIAGNOSTIC CODES IN THE VENTILATOR'S LOG HISTORY INDICATING AN OXYGEN VALVE STUCK CLOSED. UPON DETECTION OF AN OXYGEN VALVE STUCK CLOSED, THE VENTILATOR WILL CONTINUE TO FUNCTION USING AN AIR GAS SOURCE. THE VENTILATOR WILL ALARM UPON OCCURRENCE OF AN O2 VALVE STUCK CLOSED. THE CUSTOMER DID NOT REPORT THE OCCURRENCE DURING ANY PREVIOUS USAGE. THE SERVICE TECHNICIAN REPLACED THE MAIN BOARD PCB AND CPU BOARD PCB AS A PRECAUTION BASED ON THOSE FINDINGS. APPLICABLE FINAL TESTING WAS PERFORMED AND ALL TESTING PASSED PER 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