BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2973024 · Received February 21, 2013

    Report

    Report Number
    2031642-2013-00087
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    February 11, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 MANUFACTURERS SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN VERIFIED DIAGNOSTIC CODES IN THE VENTILATOR LOG HISTORY THAT INDICATED A VENTILATOR RESTART AND VENT INOP OCCURRENCES. THE SERVICE TECHNICIAN REPLACED THE CPU PCB BOARD AS A PRECAUTIONARY MEASURE. THE SERVICE TECHNICIAN REPORTED REPLACING THE DEVICE POWER CORD DUE TO DAMAGE NOTED DURING EVALUATION. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75974 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1