BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3955925 · Received July 24, 2014

    Report

    Report Number
    2031642-2014-00730
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 2, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED ON STARTUP DUE TO A VENT INOP. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE VENT INOP WAS CLEARED IN DIAGNOSTIC MODE AND NOTED THE UNIT WOULD WORK ON AC POWER BUT THE BACKUP BATTERY WAS COMPLETELY DISCHARGED. THE FSE REPORTED THE BATTERY WAS DATED (B)(6) 2007. THE FSE REPLACED THE BACKUP BATTERY TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433155 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1