BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4092824 · Received September 16, 2014

    Report

    Report Number
    2031642-2014-01044
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 22, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT

    Additional Manufacturer Narrative · 1

    AC DISTRIBUTION PANEL.PART HAS BEEN ORDERED FOR REPLACEMENT.

    Description of Event or Problem · 1

    THE SERVICE ENGINEER REPLACED THE AC DISTRIBUTION PANEL TO ADDRESS THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE DEVICE WOULD NOT TURN ON. UPON EVALUATION, THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM AND NOTED THE DEVICE SPARKING AREA OF THE AC DISTRIBUTION PANEL. THE REPORTED PROBLEM COULD AFFECT OTHER DEVICES PLUGGED INTO THE SAME CIRCUIT AND MAY RESULT IN A LOSS OF AC POWER DURING OPERATION. IF THIS FAILURE OCCURS DURING USE AND THE VENTILATOR SHUTS DOWN, AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE. THE FSE ORDERED A DISTRIBUTION PANEL FOR REPLACEMENT. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT, THEREFORE NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571020 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1