BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1901737 · Received November 17, 2010

    Report

    Report Number
    2031642-2010-00310
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOLENOID

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT WAS MOVED TO ANOTHER ROOM WITH THE VENTILATOR ATTACHED. AND THE RESPIRATORY THERAPIST (RT) REPORTED THAT THE UNIT SHOWED ZERO VOLUME DELIVERED AND ALARMED. THE RT STATED THAT THE UNIT WAS THEN TURNED OFF AND BACK ON WITH THE SAME RESULTS. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE CROSSOVER SOLENOID TO ADDRESS THE REPORTED PROBLEM. EXTENDED SELF TESTING AND APPLICABLE FINAL TESTING WERE COMPLETED AND TESTS PASSED TO 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