BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3791290 · Received May 5, 2014

    Report

    Report Number
    2031642-2014-00313
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 8, 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 SHUTDOWN DURING NORMAL VENTILATION OPERATION AND DID NOT ALARM. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. REVIEW OF THE DEVICE DIAGNOSTIC HISTORY NOTED A RESTART OCCURRENCE. THE MANUFACTURER'S FIELD SERVICE ENGINEER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SERVICE ENGINEER REPLACED THE CPU AND SENSOR PCB BOARDS AS A PRECAUTION ADDRESS THE REPORTED PROBLEM. THE SERVICE ENGINEER REPORTED THE DEVICE ALARMED PER SPECIFICATION. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268763 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1