BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2810541 · Received October 31, 2012

    Report

    Report Number
    2031642-2012-00478
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 17, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TO PERFORM SERVICE. CUSTOMER TO PERFORM SERVICE.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP AND ALARMED DURING PRE-OPERATIONAL TESTING DUE TO AN INHALATION AUTOZERO TEST FAILURE. AN AUTOZERO FAILURE DURING OPERATION IN NORMAL VENTILATION MODE MAY AFFECT THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT. THE CUSTOMER REPORTED THE 3 STATION SOLENOID, SENSOR AND ANALOG PCB BOARDS HAVE BEEN ORDERED FOR REPLACEMENT TO ADDRESS THE REPORTED PROBLEM.

    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