BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2810344 · Received October 31, 2012

    Report

    Report Number
    2031642-2012-00468
    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
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS OUT OF WARRANTY; NO REQUEST BY CUSTOMER FOR MANUFACTURER SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED DUE TO LOW INSPIRATORY PRESSURE AND LOW VOLUME. THE CUSTOMER REPORTED AIR WAS VENTING AT THE REAR OF THE UNIT AND NO VOLUME WAS DELIVERED TO THE TEST LUNG DURING TESTING. THE CUSTOMER PERFORMED EXTENDED SELF TESTING (EST) AND REPORTED EST FAILED DUE TO A CROSSOVER CIRCUIT FAULT. AS THE DEVICE WAS OUT OF WARRANTY, THE CUSTOMER ORDERED A CROSSOVER SOLENOID 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