BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4111234 · Received September 23, 2014

    Report

    Report Number
    2031642-2014-01090
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    August 26, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REQUEST MANUFACTURERS SERVICE. THE CUSTOMER DID NOT REPORT THE OCCURENCE, NO EVALUATION OR SERVICE PERFORMED.

    Description of Event or Problem · 1

    DURING SERVICE EVALUATION FOR AN UNRELATED ISSUE, A VENT INOP CONDITION AIR VALVE LIFTOFF FAILURE WAS NOTED IN THE DIAGNOSTIC LOG. SERVICE HISTORY OF THE DEVICE SHOWS THE CUSTOMER HAS NOT REPORTED THE OCCURENCE AND THERE IS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590620 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1