BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1192943 · Received October 13, 2008

    Report

    Report Number
    2031642-2008-00210
    Event Type
    Malfunction
    Date Received
    October 13, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND SHUT DOWN WHILE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN NOTED A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED A +24 VOLT POWER FAIL CONDITION. THE SERVICE TECHNICIAN REPORTED FINDING THE POWER CORD NOT FULLY INSERTED INTO THE REAR OF THE VENTILATOR, AND IF THE CORD WAS MOVED IT WOULD RESULT IN A POWER FAIL CONDITION. THE SERVICE TECHNICIAN FULLY INSERTED THE POWER CORD INTO POSITION AND TIGHTENED THE RETAINING SCREW. DURING THIS SERVICE, THE SERVICE TECHNICIAN REPORTED THAT THE CUSTOMER HAD RECENTLY PERFORMED PREVENTIVE MAINTENANCE ON THE UNIT AND HAD INSTALLED THE POWER SUPPLY FAN INCORRECTLY. THE SERVICE TECHNICIAN CORRECTED THE CUSTOMER'S ERROR BY INSTALLING THE FAN CORRECTLY. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY AS A PRECAUTION AGAINST OVERHEATING DUE TO THE CUSTOMER ERROR. PERFORMANCE VERIFICATION TESTING WAS PERFORMED AND THE VENTILATOR PASSED PER OPERATING SPECIFICATIONS.

    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