BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3980334 · Received August 5, 2014

    Report

    Report Number
    2031642-2014-00786
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE OUT OF WARRANTY; NO REQUEST FOR MANUFACTURERS SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT FAILED PRE-OPERATIONAL TESTING DUE TO A CIRCUIT LEAK. THE VENTILATOR WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE HOSPITAL BIOMEDICAL ENGINEER REPORTED THE EXHALATION VALVE WAS REPLACED TO RESOLVE THE REPORTED PROBLEM. IF THE EXHALATION VALVE IS OPEN OR LEAKING IT MAY RESULT IN A SUSTAINED OPEN EVENT WITH THE EXHALATION SYSTEM OPEN TO ATMOSPHERE AND UNABLE TO PROVIDE A PRESSURIZED BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456765 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1