BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2954136 · Received November 15, 2007

    Report

    Report Number
    2031642-2007-00210
    Event Type
    Malfunction
    Date Received
    November 15, 2007
    Date of Event
    October 19, 2007
    Report Date
    October 22, 2007
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN USE ON A PT. THE CUSTOMER REPORTED THERE WAS NO PT HARM. VENT INOP, WHEN IN SUE, WILL STOP PROVIDING VENTILATORY SUPPORT TO THE PT. THE RESPIRONICS SERVICE TECH WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. HOWEVER, THE SERVICE TECH CONFIRMED A DIAGNOSTIC CODE IN LOG HISTORY INDICATING A VENT INOP OCCURRED DUE TO AN OXYGEN MONITOR ERROR. THE SERVICE TECH REPLACED THE MAIN PCB BOARD AND SENSOR PCB AS A PRECAUTION. EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED 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 UNK