BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2113044 · Received June 3, 2011

    Report

    Report Number
    2031642-2011-00174
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 9, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND RESTARTED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN VERIFIED A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED A VENTILATOR RESTART. THE SERVICE TECHNICIAN REPLACED THE POWER SWITCH TO ADDRESS THE FINDING. 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