BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1910189 · Received November 30, 2010

    Report

    Report Number
    2031642-2010-00314
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 2, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND WENT VENT INOP WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. REVIEW OF THE VENTILATOR DIAGNOSTIC HISTORY REPORTED NO VENT INOP OCCURRENCE, HOWEVER, NOTED A VENTILATOR RESTART OCCURRENCE. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE EITHER EVENT. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS 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