BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1980857 · Received February 7, 2011

    Report

    Report Number
    2031642-2011-00028
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KINKED TUBING.

    Description of Event or Problem · 1

    DURING TESTING OF THE VENTILATOR, THE DISTRIBUTOR'S SERVICE TECHNICIAN REPORTED, THE UNIT WAS UNABLE TO OPEN THE EXHALATION AUTOZERO SOLENOID. DURING NORMAL OPERATION, THE REPORTED FAILURE COULD RESULT IN A VENT INOP OCCURRENCE. VENT INOP, WHEN IN USE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PATIENT. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED FAILURE, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT OR HARM. UPON VISUAL INSPECTION THE SERVICE TECHNICIAN REPORTED FINDING THE PRESSURE TUBING KINKED. THE KINKED TUBING WAS CORRECTED TO ADDRESS THE REPORTED PROBLEM.

    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