BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4222142 · Received November 3, 2014

    Report

    Report Number
    2031642-2014-01338
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 6, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE ALARMED AND GAVE A VENT INOP MESSAGE, MAXIMUM SYSTEM RESETS EXCEEDED. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) VERIFIED THE VENTILATOR RESTARTING. THE FSE REPLACED THE VGA PCB BOARD TO CORRECT THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS. NO PATIENT INVOLVEMENT, NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702991 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1