BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2223747 · Received August 25, 2011

    Report

    Report Number
    2031642-2011-00297
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 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

    PART REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR FAILED THE SAFETY VALVE TEST DURING TESTING DUE TO SAFETY VALVE CANNOT OPEN. THE VENTILATOR WAS NOT IN USE ON A PATIENT, THEREFORE THERE WAS NO PATIENT HARM OR INVOLVEMENT. THE DISTRIBUTOR'S SERVICE TECHNICIAN REPLACED THE 3 STATION SOLENOID ASSEMBLY TO ADDRESS THE FINDING. FAILURE TO OPEN THE SAFETY VALVE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR DURING PATIENT USE.

    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