BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3202041 · Received July 2, 2013

    Report

    Report Number
    2031642-2013-00315
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 20, 2013
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR WAS ALARMING SAFETY VALVE OPEN (SVO) DURING CHECKOUT. THE CUSTOMER REPORTED THE EXPIRATORY FILTER THAT WAS IN USE ON THE VENTILATOR WAS FOUND TO BE BLOCKED WITH SECRETIONS. THE PRESSURE TOLERANCE OF THE FILTER WAS NOT TESTED. THE CUSTOMER REPORTED THE EXPIRATORY FILTER WAS REPLACED TO CORRECT THE REPORTED PROBLEM. WHEN THE FILTER IN USE ON THIS VENTILATOR BECAME OCCLUDED, IT ALERTED THE USER WITH AN OCCLUSION-SVO ALARM/MESSAGE. WHEN AN OCCLUSION IS DETECTED DURING NORMAL VENTILATION, THE VENTILATOR WILL OPEN THE SAFETY VALVE WHICH ALLOWS THE PATIENT TO BREATHE THROUGH THE SYSTEM. WHEN THE SAFETY VALVE IS OPEN IT IS ACCOMPANIED BY AN ALARM AND A MESSAGE IN THE DISPLAY. THIS IS BEING REPORTED DUE TO USER ERROR IN MAINTENANCE OF THE FILTER. FILTER REPLACEMENT MUST BE PERFORMED PER MANUFACTURER RECOMMENDATIONS AND SPECIFIED INTERVALS. THERE WAS NO MALFUNCTION OF THE DEVICE OR THE SAFETY VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302291 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1